Cephalexin
Capsule · Oral
Uses
Cephalexin capsules USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria Respiratory tract infection ( 1.1 ) Otitis media ( 1.2 ) Skin and skin structure infections ( 1.3 ) Bone infections ( 1.4 ) Genitourinary tract infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules USP and other antibacterial drugs, cephalexin capsules USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Respiratory Tract Infections Cephalexin capsules USP are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes . 1.2 Otitis Media Cephalexin capsules USP are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae , Haemophilus influenzae , Staphylococcus aureus , Streptococcus pyogenes , and Moraxella catarrhalis . 1.3 Skin and Skin Structure Infections Cephalexin capsules USP are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes . 1.4 Bone Infections Cephalexin capsules USP are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis . 1.5 Genitourinary Tract Infections Cephalexin capsules USP are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli , Proteus mirabilis , and Klebsiella pneumoniae . 1.6 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules USP and other antibacterial drugs, cephalexin capsules USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Dosage and administration
Adults and patients at least 15 years of age The usual dose is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered ( 2.1 ). Pediatric patients (over 1 year of age)
• Otitis media: 75 to 100 mg/kg in equally divided doses every 6 hours ( 2.2 )
• All other indications: 25 to 50 mg/kg given in equally divided doses ( 2.2 )
• In severe infections: 50 to 100 mg/kg may be administered in equally divided doses ( 2.2 ) The pediatric dosage of cephalexin capsules should not exceed the adult dosage. ( 2.2 ) Duration of therapy ranges from 7 to 14 days depending on the infection type and severity. ( 2 ) Dosage adjustment is required in patients with severe and end stage renal disease (ESRD) defined as creatinine clearance below 30 mL/min. ( 2.3 ) 2.1 Recommended Dosage for Adults and Pediatric Patients at Least 15 Years of Age The recommended dosage of oral cephalexin capsules USP is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered. Treatment is administered for 7 to 14 days. For more severe infections larger doses of oral cephalexin capsules USP may be needed, up to 4 grams daily in two to four equally divided doses. 2.2 Recommended Dosage for Pediatric Patients (Over 1 year of Age) The recommended total daily dose of oral cephalexin capsules USP for pediatric patients is 25 to 50 mg/kg given in equally divided doses for 7 to 14 days. In the treatment of β-hemolytic streptococcal infections, duration of at least 10 days is recommended. In severe infections, a total daily dose of 50 to 100 mg/kg may be administered in equally divided doses. For the treatment of otitis media, the recommended daily dose is 75 to 100 mg/kg given in equally divided doses. The pediatric dosage of cephalexin capsules USP should not exceed the adult dosage. Cephalexin capsules USP should only be used in children and adolescents capable of ingesting the capsule. 2.3 Recommended Dosage in Adult and Pediatric Patients at Least 15 Years of Age with Renal Impairment Administer the following dosing regimens for cephalexin capsules USP to patients with renal impairment [ see WARNINGS AND PRECAUTIONS ( 5.4 ) and USE IN SPECIFIC POPULATIONS ( 8.6 )]. See Table 1 for dosage in adults and pediatric patients at least 15 years of age with renal impairment. There is insufficient information to recommend dosage adjustment for pediatric patients younger than 15 years of age with renal impairment. Table 1. Recommended Cephalexin Capsules Dosage for Adults Patients and Pediatric Patients (at Least 15 Years of Age) with Renal Impairment Renal function (Creatinine Clearance) Dosage recommendation Greater than or equal to 60 mL/min No dosage adjustment 30 mL/min to 59 mL/min No dosage adjustment; maximum daily dose should not exceed 1 g 15 mL/min to 29 mL/min 250 mg, every 8 hours or every 12 hours 5 mL/min to 14 mL/min not yet on dialysis There is insufficient information to make dose adjustment recommendations in patients on hemodialysis 250 mg, every 24 hours 1 mL/min to 4 mL/min not yet on dialysis 250 mg, every 48 hours or every 60 hours
Dosage forms and strengths
Capsules: 250 mg and 500 mg ( 3 ) 250 mg Capsules A white to yellowish-white granular powder filled into size "2" capsules (white and dark green) that are imprinted with "250" on dark green cap, and "LUPIN" on the white body in edible black ink. 500 mg Capsules A white to yellowish-white granular powder filled into size "0" capsules (light green and dark green) that are imprinted with "500" on the dark green cap, and "LUPIN" on the light green body in edible black ink.
Contraindications
Patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs. ( 4 ) Cephalexin capsules are contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.
Warnings and precautions
Serious hypersensitivity (anaphylactic) reactions : Prior to use, inquire regarding history of hypersensitivity to beta-lactam antibacterial drugs. Discontinue the drug if signs or symptoms of an allergic reaction occur and institute supportive measures. ( 5.1 ) Clostridioides difficile -Associated Diarrhea (CDAD) : Evaluate if diarrhea occurs. ( 5.2 ) Direct Coombs' Test Seroconversion : If anemia develops during or after cephalexin therapy, evaluate for drug-induced hemolytic anemia.( 5.3 ) Seizure Potential : Use lower dose in patients with renal impairment. ( 5.4 ) 5.1 Hypersensitivity Reactions Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been reported with the use of cephalexin. Before therapy with cephalexin capsules is instituted, inquire whether the patient has a history of hypersensitivity reactions to cephalexin, cephalosporins, penicillins, or other drugs. Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to cephalexin occurs, discontinue the drug and institute appropriate treatment. 5.2 Clostridioides difficile -Associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cephalexin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. 5.3 Direct Coombs’ Test Seroconversion Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibacterial drugs including cephalexin. Acute intravascular hemolysis induced by cephalexin therapy has been reported. If anemia develops during or after cephalexin therapy, perform a diagnostic work-up for drug-induced hemolytic anemia, discontinue cephalexin and institute appropriate therapy. 5.4 Seizure Potential Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures occur, discontinue cephalexin. Anticonvulsant therapy can be given if clinically indicated. 5.5 Prolonged Prothrombin Time Cephalosporins may be associated with prolonged prothrombin time. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antibacterial therapy, and patients receiving anticoagulant therapy. Monitor prothrombin time in patients at risk and manage as indicated. 5.6 Development of Drug-Resistant Bacteria Prescribing cephalexin capsules in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Prolonged use of cephalexin may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Side effects
The most common adverse reactions associated with cephalexin include diarrhea, nausea, vomiting, dyspepsia and abdominal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious events are described in greater detail in the Warning and Precautions section: Hypersensitivity Reactions [see WARNING AND PRECAUTIONS ( 5.1 )] Clostridioides difficile -Associated Diarrhea [see WARNINGS AND PRECAUTIONS ( 5.2 )] Direct Coombs' Test Seroconversion [see WARNINGS AND PRECAUTIONS ( 5.3 )] Seizure Potential [see WARNINGS AND PRECAUTIONS ( 5.4 )] Prolonged Prothrombin Time [see WARNINGS AND PRECAUTIONS ( 5.5 )] Development of Drug-Resistant Bacteria [see WARNINGS AND PRECAUTIONS ( 5.6 )] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, the most frequent adverse reaction was diarrhea. Nausea and vomiting, dyspepsia, gastritis, and abdominal pain have also occurred. As with penicillins and other cephalosporins, transient hepatitis and cholestatic jaundice have been reported. Other reactions have included hypersensitivity reactions, genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported. Eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in aspartate transaminase (AST) and alanine transaminase (ALT) have been reported. In addition to the adverse reactions listed above that have been observed in patients treated with cephalexin, the following adverse reactions and other altered laboratory tests have been reported for cephalosporin class antibacterial drugs: Other Adverse Reactions Fever, colitis, aplastic anemia, hemorrhage, renal dysfunction, and toxic nephropathy. Altered Laboratory Tests Prolonged prothrombin time, increased blood urea nitrogen (BUN), increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated lactate dehydrogenase (LDH), pancytopenia, leukopenia, and agranulocytosis.
Drug interactions
Metformin: increased metformin concentrations. Monitor for hypoglycemia. ( 7.1 ) Probenecid: The renal excretion of cephalexin is inhibited by probenecid. Co-administration of probenecid with cephalexin is not recommended. ( 7.2 ) Administration of cephalexin may result in a false-positive reaction glucose in the urine. ( 7.3 ) 7.1 Metformin Administration of cephalexin with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin. Careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin [see CLINICAL PHARMACOLOGY ( 12.3 ]. 7.2 Probenecid The renal excretion of cephalexin is inhibited by probenecid. Co-administration of probenecid with cephalexin capsules is not recommended. 7.3 Interaction with Laboratory or Diagnostic Testing A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict's solution or Fehling's solution.
Use in specific populations
Renal Impairment: Monitor patients longer for toxicity and drug interactions due to delayed clearance. ( 8.6 ) 8.1 Pregnancy Risk Summary Available data from published epidemiologic studies and pharmacovigilance case reports over several decades of cephalexin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal reproduction studies with mice and rats using oral doses of cephalexin that are 0.6- and 1.2-times the maximum recommended human dose (MRHD) based on body surface area during organogenesis revealed no evidence of harm to the fetus (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown.All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data: In animal reproduction studies, pregnant mice and rats administered oral cephalexin doses of 250 or 500 mg/kg/day (approximately 0.6 and 1.2 times the MRHD) based on body surface area, respectively during the period of organogenesis showed no adverse effects on embryofetal development. In a pre-and post-natal developmental toxicity study, pregnant rats that received oral doses of 250 or 500 mg/kg/day of cephalexin from Day 15 of pregnancy to litter Day 21 showed no adverse effects on parturition, litter size, or growth of offspring. 8.2 Lactation Risk Summary Data from a published clinical lactation study reports that cephalexin is present in human milk. The relative infant dose (RID) is considered to be <1% of the maternal weight adjusted dose. There are limited data on the effects of cephalexin on the breastfed child. There are no data on the effects of cephalexin on milk production. The developmental of health benefits of breastfeeding should be considered along with the mother's clinical need for cephalexin and any potential adverse effects on the breastfed child from cephalexin or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of cephalexin capsules in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section [see DOSAGE AND ADMINISTRATION ( 2.2 )]. The safety and effectiveness of cephalexin capsules have not been established in pediatric patients younger than one year old. 8.5 Geriatric Use Of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [see WARNINGS AND PRECAUTIONS ( 5.4 )]. 8.6 Renal Impairment Cephalexin capsules should be administered with careful monitoring in the presence of renal impairment (creatinine clearance < 30 mL/min, with or without dialysis). Under such conditions, careful clinical observation and laboratory studies including renal function monitoring should be conducted because safe dosage may be lower than that usually recommended [see DOSAGE AND ADMINISTRATION ( 2.3 )]. Monitor patients longer for toxicity and drug interactions due to delayed clearance. There is insufficient information to recommend dosage adjustment for pediatric patients younger than 15 years of age with renal impairment [see Dosage and Administration ( 2.4 )].
Pregnancy
8.1 Pregnancy Risk Summary Available data from published epidemiologic studies and pharmacovigilance case reports over several decades of cephalexin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal reproduction studies with mice and rats using oral doses of cephalexin that are 0.6- and 1.2-times the maximum recommended human dose (MRHD) based on body surface area during organogenesis revealed no evidence of harm to the fetus (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown.All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data: In animal reproduction studies, pregnant mice and rats administered oral cephalexin doses of 250 or 500 mg/kg/day (approximately 0.6 and 1.2 times the MRHD) based on body surface area, respectively during the period of organogenesis showed no adverse effects on embryofetal development. In a pre-and post-natal developmental toxicity study, pregnant rats that received oral doses of 250 or 500 mg/kg/day of cephalexin from Day 15 of pregnancy to litter Day 21 showed no adverse effects on parturition, litter size, or growth of offspring.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of cephalexin capsules in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section [see DOSAGE AND ADMINISTRATION ( 2.2 )]. The safety and effectiveness of cephalexin capsules have not been established in pediatric patients younger than one year old.
Geriatric use
8.5 Geriatric Use Of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [see WARNINGS AND PRECAUTIONS ( 5.4 )].
Overdosage
Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. In the event of an overdose, institute general supportive measures. Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cephalexin.
Description
Cephalexin capsules USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7- (D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16 H 17 N 3 O 4 S
• H 2 O and the molecular weight is 365.41. Cephalexin has the following structural formula: Each capsule contains cephalexin USP equivalent to 250 mg, or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&C Yellow 10, FD&C Blue 1, FD&C Green 3, FD&C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide. image-01
Mechanism of action
12.1 Mechanism of Action Cephalexin is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )].
How supplied
Cephalexin capsules USP, are supplied as follows: 250 mg Capsules, Bottles of 100 NDC 68180-121-01 Bottles of 500 NDC 68180-121-02 500 mg Capsules, Bottles of 100 NDC 68180-122-01 Bottles of 500 NDC 68180-122-02 Cephalexin capsules USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
Patient information
Allergic Reactions Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to cephalexin capsules, other beta-lactams (including cephalosporins) or other allergens ( 5.1 ) Diarrhea Advise patients that diarrhea is a common problem caused by antibacterial drugs and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, advise patients to contact their healthcare provider. Antibacterial Resistance Patients should be counseled that antibacterial drugs including cephalexin capsules, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin capsules are prescribed to treat a bacterial infection, patients should be told that that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cephalexin capsules or other antibacterial drugs in the future Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States. Manufactured by: Lupin Limited Mandideep (M.P.) - 462046 India Revised: August 2026 ID#: 284873 trade mark
Label text from the FDA structured product label by Lupin Pharmaceuticals, Inc. (revised Aug 24, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Cephalexin in 184 products
Cephalexin NDC products (184)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-6445 | Cephalexin 250 mg/5mL For Suspension | A-S Medication Solutions | ANDA |
| 50090-3252 | Cephalexin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-3202 | Cephalexin 250 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-3199 | Cephalexin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-0081 | Cephalexin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-0080 | Cephalexin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-0079 | Cephalexin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-3291 | Cephalexin 250 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-3427 | Cephalexin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-4422 | Cephalexin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-4795 | Cephalexin 250 mg/5mL For Suspension | A-S Medication Solutions | ANDA |
| 50090-5196 | Cephalexin 250 mg/5mL For Suspension | A-S Medication Solutions | ANDA |
| 50090-5948 | Cephalexin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-7026 | Cephalexin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-7027 | Cephalexin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-7091 | Cephalexin 250 mg/5mL For Suspension | A-S Medication Solutions | ANDA |
| 50090-7162 | Cephalexin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-7223 | Cephalexin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-7224 | Cephalexin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 80425-0004 | Cephalexin 500 mg/1 Capsule | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA |
| 80425-0005 | Cephalexin 500 mg/1 Capsule | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA |
| 80425-0006 | Cephalexin 500 mg/1 Capsule | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA |
| 80425-0121 | Cephalexin 500 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 72287-310 | Cephalexin 500 mg/1 Capsule | AMELLA PHARMA, LLC | ANDA |
| 60687-152 | Cephalexin 250 mg/1 Capsule | American Health Packaging | ANDA |
| 60687-163 | Cephalexin 500 mg/1 Capsule | American Health Packaging | ANDA |
| 67877-892 | Cephalexin 500 mg/1 Tablet | Ascend Laboratories, LLC | ANDA |
| 67877-891 | Cephalexin 250 mg/1 Tablet | Ascend Laboratories, LLC | ANDA |
| 67877-545 | Cephalexin 250 mg/5mL For Suspension | Ascend Laboratories, LLC | ANDA |
| 67877-544 | Cephalexin 125 mg/5mL For Suspension | Ascend Laboratories, LLC | ANDA |
| 67877-255 | Cephalexin 750 mg/1 Capsule | Ascend Laboratories, LLC | ANDA |
| 67877-254 | Cephalexin 333 mg/1 Capsule | Ascend Laboratories, LLC | ANDA |
| 67877-220 | Cephalexin 250 mg/1 Capsule | Ascend Laboratories, LLC | ANDA |
| 67877-219 | Cephalexin 500 mg/1 Capsule | Ascend Laboratories, LLC | ANDA |
| 76420-831 | Cephalexin 500 mg/1 Capsule | Asclemed USA, Inc | ANDA |
| 76420-287 | Cephalexin 250 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-034 | Cephalexin 250 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-754 | Cephalexin 250 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-736 | Cephalexin 500 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-595 | Cephalexin 750 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-594 | Cephalexin 250 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-593 | Cephalexin 333 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-592 | Cephalexin 500 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-288 | Cephalexin 500 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-052 | Cephalexin 500 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 65862-018 | Cephalexin 250 mg/1 Capsule | Aurobindo Pharma Limited | ANDA |
| 65862-019 | Cephalexin 500 mg/1 Capsule | Aurobindo Pharma Limited | ANDA |
| 59651-783 | Cephalexin 250 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-728 | Cephalexin 750 mg/1 Capsule | Aurobindo Pharma Limited | ANDA |
| 59651-323 | Cephalexin 250 mg/5mL Powder, For Suspension | Aurobindo Pharma Limited | ANDA |
| 59651-322 | Cephalexin 125 mg/5mL Powder, For Suspension | Aurobindo Pharma Limited | ANDA |
| 59651-784 | Cephalexin 500 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 42291-006 | Cephalexin 250 mg/1 Capsule | AVKARE | ANDA |
| 42291-007 | Cephalexin 500 mg/1 Capsule | AVKARE | ANDA |
| 42291-208 | Cephalexin 250 mg/1 Capsule | AvKARE | ANDA |
| 42291-209 | Cephalexin 500 mg/1 Capsule | AvKARE | ANDA |
| 50268-152 | Cephalexin 500 mg/1 Capsule | AvPAK | ANDA |
| 50268-151 | Cephalexin 250 mg/1 Capsule | AvPAK | ANDA |
| 63629-9207 | Cephalexin 250 mg/5mL For Suspension | Bryant Ranch Prepack | ANDA |
| 63629-9206 | Cephalexin 250 mg/5mL For Suspension | Bryant Ranch Prepack | ANDA |
| 63629-9205 | Cephalexin 125 mg/5mL For Suspension | Bryant Ranch Prepack | ANDA |
| 63629-9204 | Cephalexin 125 mg/5mL For Suspension | Bryant Ranch Prepack | ANDA |
| 63629-9203 | Cephalexin 750 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-9435 | Cephalexin 750 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-9436 | Cephalexin 750 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-2704 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-9202 | Cephalexin 750 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 72162-1851 | Cephalexin 250 mg/5mL For Suspension | Bryant Ranch Prepack | ANDA |
| 71335-2864 | Cephalexin 250 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-2877 | Cephalexin 250 mg/5mL For Suspension | Bryant Ranch Prepack | ANDA |
| 72162-1850 | Cephalexin 125 mg/5mL For Suspension | Bryant Ranch Prepack | ANDA |
| 72162-1833 | Cephalexin 750 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 72162-1831 | Cephalexin 250 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 72162-1830 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-2986 | Cephalexin 250 mg/5mL For Suspension | Bryant Ranch Prepack | ANDA |
| 71335-2976 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-9200 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-2685 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 71335-2734 | Cephalexin 250 mg/5mL For Suspension | Bryant Ranch Prepack | ANDA |
| 72162-2607 | Cephalexin 250 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 72162-2145 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-4219 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-4222 | Cephalexin 250 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-5740 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-5741 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-5742 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-7621 | Cephalexin 250 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-7740 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-7742 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-7743 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-7927 | Cephalexin 250 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-8184 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-8854 | Cephalexin 250 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-8855 | Cephalexin 250 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-8856 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-8857 | Cephalexin 250 mg/5mL For Suspension | Bryant Ranch Prepack | ANDA |
| 63629-8858 | Cephalexin 250 mg/5mL For Suspension | Bryant Ranch Prepack | ANDA |
| 63629-9198 | Cephalexin 250 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-9199 | Cephalexin 250 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-9201 | Cephalexin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 62135-710 | Cephalexin 250 mg/1 Capsule | Chartwell RX, LLC | ANDA |
| 62135-481 | Cephalexin 250 mg/5mL Powder, For Suspension | Chartwell RX, LLC | ANDA |
| 62135-480 | Cephalexin 125 mg/5mL Powder, For Suspension | Chartwell RX, LLC | ANDA |
| 62135-711 | Cephalexin 500 mg/1 Capsule | Chartwell RX, LLC. | ANDA |
| 67046-1245 | Cephalexin 500 mg/1 Capsule | Coupler LLC | ANDA |
| 67046-1533 | Cephalexin 250 mg/1 Capsule | Coupler, LLC | ANDA |
| 69043-008 | Cephalexin 250 mg/1 Capsule | Cronus Pharma LLC | ANDA |
| 69043-009 | Cephalexin 500 mg/1 Capsule | Cronus Pharma LLC | ANDA |
| 61919-606 | Cephalexin 500 mg/1 Capsule | DIRECT RX | ANDA |
| 85534-0076 | Cephalexin 250 mg/1 Capsule | HAWAII REPACK, INC. | ANDA |
| 85534-0077 | Cephalexin 333 mg/1 Capsule | HAWAII REPACK, INC. | ANDA |
| 85534-0079 | Cephalexin 750 mg/1 Capsule | HAWAII REPACK, INC. | ANDA |
| 85534-0078 | Cephalexin 500 mg/1 Capsule | HAWAII REPACK, INC. | ANDA |
| 68180-121 | Cephalexin 250 mg/1 Capsule | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-122 | Cephalexin 500 mg/1 Capsule | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-440 | Cephalexin 125 mg/5mL For Suspension | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-441 | Cephalexin 250 mg/5mL For Suspension | Lupin Pharmaceuticals, Inc. | ANDA |
| 0904-7337 | Cephalexin 500 mg/1 Capsule | Major Pharmaceuticals | ANDA |
| 0904-7336 | Cephalexin 250 mg/1 Capsule | Major Pharmaceuticals | ANDA |
| 82868-095 | Cephalexin 500 mg/1 Capsule | Northwind Health Company, LLC | ANDA |
| 82868-057 | Cephalexin 500 mg/1 Capsule | Northwind Health Company, LLC | ANDA |
| 68071-3740 | Cephalexin 250 mg/1 Capsule | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3680 | Cephalexin 250 mg/1 Capsule | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-4429 | Cephalexin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5038 | Cephalexin 250 mg/5mL For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4406 | Cephalexin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4355 | Cephalexin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3587 | Cephalexin 250 mg/5mL For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3538 | Cephalexin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3532 | Cephalexin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2889 | Cephalexin 250 mg/5mL For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2249 | Cephalexin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2246 | Cephalexin 125 mg/5mL For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 66267-982 | Cephalexin 250 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4516 | Cephalexin 250 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5241 | Cephalexin 250 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4465 | Cephalexin 250 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4434 | Cephalexin 250 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 72789-252 | Cephalexin 250 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 55289-058 | Cephalexin 500 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-251 | Cephalexin 500 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 55289-057 | Cephalexin 250 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-678 | Cephalexin 250 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-634 | Cephalexin 500 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-536 | Cephalexin 500 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-497 | Cephalexin 250 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 69778-931 | Cephalexin 500 mg/1 Capsule | Pharma-C, Inc. | ANDA |
| 69778-930 | Cephalexin 250 mg/1 Capsule | Pharma-C, Inc. | ANDA |
| 68788-8740 | Cephalexin 500 mg/1 Capsule | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8538 | Cephalexin 500 mg/1 Capsule | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8686 | Cephalexin 250 mg/5mL For Suspension | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4167 | Cephalexin 250 mg/1 Capsule | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4143 | Cephalexin 500 mg/1 Capsule | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7529 | Cephalexin 250 mg/5mL For Suspension | Preferred Pharmaceuticals, Inc. | ANDA |
| 68788-7796 | Cephalexin 125 mg/5mL For Suspension | Preferred Pharmaceuticlas Inc. | ANDA |
| 63187-205 | Cephalexin 250 mg/5mL Powder, For Suspension | Proficient Rx LP | ANDA |
| 63187-046 | Cephalexin 500 mg/1 Capsule | Proficient Rx LP | ANDA |
| 71205-672 | Cephalexin 500 mg/1 Capsule | Proficient Rx LP | ANDA |
| 71205-591 | Cephalexin 500 mg/1 Capsule | Proficient Rx LP | ANDA |
| 71205-553 | Cephalexin 250 mg/5mL For Suspension | Proficient Rx LP | ANDA |
| 82804-106 | Cephalexin 500 mg/1 Capsule | Proficient Rx LP | ANDA |
| 42708-017 | Cephalexin 500 mg/1 Capsule | QPharma Inc | ANDA |
| 42708-145 | Cephalexin 250 mg/1 Capsule | QPharma Inc | ANDA |
| 42708-100 | Cephalexin 250 mg/1 Capsule | QPharma Inc | ANDA |
| 42708-070 | Cephalexin 500 mg/1 Capsule | QPharma Inc | ANDA |
| 70518-3857 | Cephalexin 500 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-2273 | Cephalexin 250 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-3059 | Cephalexin 500 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-3066 | Cephalexin 500 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-3362 | Cephalexin 500 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-3378 | Cephalexin 500 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-4511 | Cephalexin 250 mg/5mL For Suspension | REMEDYREPACK INC. | ANDA |
| 70518-4250 | Cephalexin 250 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-3448 | Cephalexin 500 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 85766-004 | Cephalexin 500 mg/1 Capsule | Sportpharm LLC | ANDA |
| 85766-005 | Cephalexin 250 mg/1 Capsule | Sportpharm LLC | ANDA |
| 85766-191 | Cephalexin 500 mg/1 Capsule | Sportpharm LLC | ANDA |
| 0093-2240 | Cephalexin 500 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-4177 | Cephalexin 250 mg/5mL Powder, For Suspension | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-4175 | Cephalexin 125 mg/5mL Powder, For Suspension | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-3147 | Cephalexin 500 mg/1 Capsule | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-3145 | Cephalexin 250 mg/1 Capsule | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-2238 | Cephalexin 250 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 87441-004 | Cephalexin 500 mg/1 Capsule | Unit Dose Solutions, Inc. | ANDA |
Cephalexin recalls
- D-0468-2025 Jun 18, 2025 · Class II · Ongoing
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin… - D-0469-2025 Jun 18, 2025 · Class II · Ongoing
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin… - D-0540-2024 Jun 12, 2024 · Class III · Ongoing
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g' - D-0536-2024 Jun 12, 2024 · Class III · Ongoing
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g' - D-0537-2024 Jun 12, 2024 · Class III · Ongoing
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g - D-0538-2024 Jun 12, 2024 · Class III · Ongoing
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g' - D-0539-2024 Jun 12, 2024 · Class III · Ongoing
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g' - D-0342-2021 May 5, 2021 · Class II · Ongoing
Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin - D-0263-2021 Feb 24, 2021 · Class II · Terminated
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. - D-0264-2021 Feb 24, 2021 · Class II · Terminated
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. - D-0185-2021 Jan 13, 2021 · Class II · Terminated
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL. - D-0178-2021 Jan 6, 2021 · Class II · Terminated
Failed Impurity/Degradation Specifications - D-0179-2021 Jan 6, 2021 · Class II · Terminated
Failed Impurity/Degradation Specifications - D-0013-2021 Sep 16, 2020 · Class II · Terminated
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits. - D-1566-2020 Sep 16, 2020 · Class II · Terminated
Sub-Potent Drug: Out of specification test results for potency (below specification). - D-0012-2021 Sep 16, 2020 · Class II · Terminated
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits. - D-0423-2019 Feb 6, 2019 · Class II · Terminated
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the…
Frequently asked questions
What is Cephalexin used for?
Cephalexin capsules USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria Respiratory tract infection ( 1.1 ) Otitis media ( 1.2 ) Skin and skin structure infections ( 1.3 ) Bone infections ( 1.4 ) Genitourinary tract infections ( 1.5 ) To reduce the development of drug-resistant bacteria and…
What are the side effects of Cephalexin?
The most common adverse reactions associated with cephalexin include diarrhea, nausea, vomiting, dyspepsia and abdominal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious events are described in greater detail in the Warning and Precautions section: Hypersensitivity… See the full label for the complete list.
Who makes Cephalexin?
Cephalexin is listed by 36 labelers in the FDA NDC directory, including A-S Medication Solutions, ADVANCED RX PHARMACY OF TENNESSEE, LLC, Advanced Rx Pharmacy of Tennessee, LLC, AMELLA PHARMA, LLC.
Has Cephalexin been recalled?
The FDA enforcement database lists 17 recalls for Cephalexin, most recently D-0468-2025 (class ii): Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability…