atropine sulfate
Injection, Solution · Intravenous, Intramuscular, Subcutaneous
Current shortage
Atropine Sulfate, Injection, .1 mg/1 mL (NDC 16729-484-90) – Unavailable (Accord Healthcare Inc., updated Sep 15, 2026)
Discontinuation of the manufacture of the drug
Atropine Sulfate, Injection, 1 mg/1 mL (NDC 0517-1001-25) – Available (American Regent, Inc., updated Sep 15, 2026)
Atropine Sulfate, Injection, 0.4 mg/1 mL (NDC 0641-6251-10) – Available (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 63323-580-20) – Available (Fresenius Kabi USA, LLC, updated Sep 1, 2026)
Check wholesalers for inventory
Atropine Sulfate, Injection, 1 mg/10 mL (0.1 mg/mL) Syringes (NDC 64253-400-91) – Available (Medefil, Inc., updated Sep 15, 2026)
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 70069-631-25) – Available (Somerset Therapeutics, LLC, updated Sep 11, 2026)
Atropine Sulfate, Injection, 1 mg/1 mL (NDC 70069-641-25) – Available (Somerset Therapeutics, LLC, updated Sep 11, 2026)
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 0517-1004-25) – Available (American Regent, Inc., updated Sep 15, 2026)
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 70069-481-10) – Available (Somerset Therapeutics, LLC, updated Sep 11, 2026)
Atropine Sulfate, Injection, 1 mg/10 mL (0.1 mg/mL) Syringes (NDC 0409-1630-10) – Unavailable (Hospira, Inc., a Pfizer Company, updated Aug 24, 2026)
Next Delivery: August 2026; Estimated Recovery: September 2026; Shortage per Manufacturer: Manufacturing Delay
Uses
Atropine Sulfate Injection is indicated for temporary blockade of severe or life‑threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life‑threatening muscarinic effects. ( 1 )
Dosage and administration
• For intravenous administration ( 2.1 )
• Titrate according to heart rate, PR interval, blood pressure and symptoms ( 2.1 )
• Adult dosage - Antisialagogue or for antivagal effects: Initial single dose of 0.5 mg to 1 mg ( 2.2 ) - Antidote for organophosphorus or muscarinic mushroom poisoning: Initial single dose of 2 mg to 3 mg, repeated every 20-30 minutes ( 2.2 ) - Bradyasystolic cardiac arrest: 1 mg dose, repeated every 3-5 minutes if asystole persists ( 2.2 )
• Patients with Coronary Artery Disease: Limit the total dose to 0.03 mg/kg to 0.04 mg/kg ( 2.4 ) 2.1 General Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Each syringe is intended for single dose only. Discard unused portion. For intravenous administration. Titrate based on heart rate, PR interval, blood pressure and symptoms. 2.2 Adult Dosage Table 1: Recommended Dosage Use Dose (adults) Repeat Antisialagogue or other antivagal 0.5 to 1 mg 1-2 hours Organophosphorus or muscarinic mushroom poisoning 2 to 3 mg 20-30 minutes Bradyasystolic cardiac arrest 1 mg 3-5 minutes; 3 mg maximum total dose 2.3 Pediatric Dosage Dosing in pediatric populations has not been well studied. Usual initial dose is 0.01 to 0.03 mg/kg. 2.4 Dosing in Patients with Coronary Artery Disease Limit the total dose of atropine sulfate to 0.03 mg/kg to 0.04 mg/kg [see Warnings and Precautions (5.1) ] .
Dosage forms and strengths
Injection: 0.05 mg/mL and 0.1 mg/mL in Ansyr ® Plastic Syringe. Injection: 0.1 mg/mL in LifeShield ® Abboject ® Glass Syringe.
• 0.05 mg/mL injection in Ansyr ® Plastic Syringe ( 3 )
• 0.1 mg/mL injection in Ansyr ® Plastic Syringe ( 3 )
• 0.1 mg/mL injection in LifeShield ® Abboject ® Glass Syringe ( 3 )
Contraindications
None. None. ( 4 )
Warnings and precautions
• Tachycardia ( 5.1 )
• Glaucoma ( 5.2 )
• Pyloric obstruction ( 5.3 )
• Worsening urinary retention ( 5.4 )
• Viscid bronchial plugs ( 5.5 ) 5.1 Tachycardia When the recurrent use of atropine is essential in patients with coronary artery disease, the total dose should be restricted to 2 to 3 mg (maximum 0.03 to 0.04 mg/kg) to avoid the detrimental effects of atropine‑induced tachycardia on myocardial oxygen demand. 5.2 Acute Glaucoma Atropine may precipitate acute glaucoma. 5.3 Pyloric Obstruction Atropine may convert partial organic pyloric stenosis into complete obstruction. 5.4 Complete Urinary Retention Atropine may lead to complete urinary retention in patients with prostatic hypertrophy. 5.5 Viscid Plugs Atropine may cause inspissation of bronchial secretions and formation of viscid plugs in patients with chronic lung disease.
Side effects
The following adverse reactions have been identified during post-approval use of atropine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur. Anhidrosis can produce heat intolerance. Constipation and difficulty in micturition may occur in elderly patients. Occasional hypersensitivity reactions have been observed, especially skin rashes which in some instances progressed to exfoliation. Most adverse reactions are directly related to atropine’s antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur with chronic administration of therapeutic doses. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug interactions
Mexiletine: Decreases rate of mexiletine absorption. ( 7.1 ) 7.1 Mexiletine Atropine Sulfate Injection decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this delay in mexiletine absorption was reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia.
Use in specific populations
8.1 Pregnancy Risk Summary There are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see Clinical Considerations ) . Available data from published observational studies on atropine sulfate use in pregnant women are insufficient to evaluate for a drug‑associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . Animal developmental and reproductive toxicity studies have not been conducted with atropine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Severe or life-threatening muscarinic events such as acute organophosphate poisoning and symptomatic bradycardia are medical emergencies in pregnancy which can be fatal if left untreated. Life-sustaining therapy for the pregnant woman should not be withheld because of concerns regarding the effects of atropine on the fetus. Data Human Data Atropine crosses the placenta [see Clinical Pharmacology (12.3) ] . No adequate and well-controlled studies are available regarding use of atropine in pregnant women. In a cohort study of 401 pregnancies in the first trimester and 797 pregnancies in the second or third trimester, atropine use was not associated with an increased risk of congenital malformations. In a surveillance study, 381 newborns were exposed to atropine during the first trimester; 18 major birth defects were observed when 16 were expected. No specific pattern of major defects was identified. In another surveillance study of 50 pregnancies in the first trimester, atropine use was not associated with an increased risk of malformations. Methodological limitations of these observational studies including the inability to control for the dosage and timing of atropine exposure, underlying maternal disease, or concomitant maternal drug use, cannot definitively establish or exclude any drug-associated risk during pregnancy. 8.2 Lactation Risk Summary Trace amounts of atropine have been reported in human milk. There are no available data on atropine levels in human milk after intravenous injection, the effects on the breastfed infant, or the effects on milk production. Clinical Considerations Minimizing Exposure The elimination half-life of atropine is more than doubled in children less than 2 years of age [see Clinical Pharmacology (12.3) ] . To minimize potential infant exposure to Atropine Sulfate Injection, a woman may pump and discard her milk for 24 hours after use before resuming to breastfeed her infant. 8.4 Pediatric Use Recommendations for use in pediatric patients are not based on clinical trials. 8.5 Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Pregnancy
8.1 Pregnancy Risk Summary There are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see Clinical Considerations ) . Available data from published observational studies on atropine sulfate use in pregnant women are insufficient to evaluate for a drug‑associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . Animal developmental and reproductive toxicity studies have not been conducted with atropine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Severe or life-threatening muscarinic events such as acute organophosphate poisoning and symptomatic bradycardia are medical emergencies in pregnancy which can be fatal if left untreated. Life-sustaining therapy for the pregnant woman should not be withheld because of concerns regarding the effects of atropine on the fetus. Data Human Data Atropine crosses the placenta [see Clinical Pharmacology (12.3) ] . No adequate and well-controlled studies are available regarding use of atropine in pregnant women. In a cohort study of 401 pregnancies in the first trimester and 797 pregnancies in the second or third trimester, atropine use was not associated with an increased risk of congenital malformations. In a surveillance study, 381 newborns were exposed to atropine during the first trimester; 18 major birth defects were observed when 16 were expected. No specific pattern of major defects was identified. In another surveillance study of 50 pregnancies in the first trimester, atropine use was not associated with an increased risk of malformations. Methodological limitations of these observational studies including the inability to control for the dosage and timing of atropine exposure, underlying maternal disease, or concomitant maternal drug use, cannot definitively establish or exclude any drug-associated risk during pregnancy.
Pediatric use
8.4 Pediatric Use Recommendations for use in pediatric patients are not based on clinical trials.
Geriatric use
8.5 Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Overdosage
Excessive dosing may cause palpitation, dilated pupils, difficulty in swallowing, hot dry skin, thirst, dizziness, restlessness, tremor, fatigue and ataxia. Toxic doses lead to restlessness and excitement, hallucinations, delirium and coma. Depression and circulatory collapse occur only with severe intoxication. In such cases, blood pressure declines and death due to respiratory failure may ensue following paralysis and coma. The fatal adult dose of atropine is not known. In pediatric populations, 10 mg or less may be fatal. In the event of toxic overdosage, a short acting barbiturate or diazepam may be given as needed to control marked excitement and convulsions. Large doses for sedation should be avoided because central depressant action may coincide with the depression occurring late in atropine poisoning. Central stimulants are not recommended. Physostigmine, given as an atropine antidote by slow intravenous injection of 1 to 4 mg (0.5 to 1 mg in pediatric populations), rapidly abolishes delirium and coma caused by large doses of atropine. Since physostigmine is rapidly destroyed, the patient may again lapse into coma after one to two hours, and repeated doses may be required. Artificial respiration with oxygen may be necessary. Ice bags and alcohol sponges help to reduce fever, especially in pediatric populations. Atropine is not removed by dialysis.
Description
Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection. Each milliliter (mL) contains 0.1 mg (adult strength) or 0.05 mg (pediatric strength) of atropine sulfate monohydrate equivalent to 0.083 mg (adult strength) or 0.042 mg (pediatric strength) of atropine, and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment 0.308 mOsmol/mL (calc.). pH 3.0 to 6.5. Sodium chloride added to render the solution isotonic for injection of the active ingredient is present in amounts insufficient to affect serum electrolyte balance of sodium (Na + ) and chloride (Cl - ) ions. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine Sulfate, USP is chemically designated 1α H, 5α H-Tropan-3-α-ol (±)-tropate (ester), sulfate (2:1) (salt) monohydrate, (C 17 H 23 NO 3 ) 2 H 2 SO 4 H 2 O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula: Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and 1‑hyocyamine, whose activity is due almost entirely to the levo isomer of the drug. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. The Ansyr ® syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material. structural formula atropine sulfate
Mechanism of action
12.1 Mechanism of Action Atropine is an antimuscarinic agent since it antagonizes the muscarine-like actions of acetylcholine and other choline esters. Atropine inhibits the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves, and on smooth muscles which respond to endogenous acetylcholine but are not so innervated. As with other antimuscarinic agents, the major action of atropine is a competitive or surmountable antagonism which can be overcome by increasing the concentration of acetylcholine at receptor sites of the effector organ (e.g., by using anticholinesterase agents which inhibit the enzymatic destruction of acetylcholine). The receptors antagonized by atropine are the peripheral structures that are stimulated or inhibited by muscarine (i.e., exocrine glands and smooth and cardiac muscle). Responses to postganglionic cholinergic nerve stimulation also may be inhibited by atropine but this occurs less readily than with responses to injected (exogenous) choline esters.
How supplied
Atropine Sulfate Injection, USP is supplied in single-dose syringes as follows: Unit of Sale and Product Description Strength (Concentration) NDC Bundle of 10 5 mL Single-Dose Ansyr ® Plastic Syringe 0.25 mg/5 mL (0.05 mg/mL) 0409-9630-05 Bundle of 10 10 mL Single-Dose Ansyr ® Plastic Syringe 1 mg/10 mL (0.1 mg/mL) 0409-1630-10 Bundle of 10 5 mL Single-Dose LifeShield ® Abboject ® Glass Syringe 0.5 mg/5 mL (0.1 mg/mL) 0409-4910-34 Bundle of 10 10 mL Single-Dose LifeShield ® Abboject ® Glass Syringe 1 mg/10 mL (0.1 mg/mL) 0409-4911-34 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Abboject ® is a trademark of Abbott Laboratories. LifeShield ® is the trademark of ICU Medical, Inc. and is used under license. LAB-1041-7.0 Hospira Logo
Label text from the FDA structured product label by Hospira, Inc. (revised May 18, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Atropine Sulfate in 62 products
atropine sulfate NDC products (62)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-5924 | Atropine Sulfate .1 mg/mL Injection | A-S Medication Solutions | ANDA |
| 16729-512 | Atropine Sulfate .4 mg/mL Injection, Solution | Accord Healthcare Inc. | ANDA |
| 16729-484 | Atropine Sulfate .1 mg/mL Injection | Accord Healthcare, Inc., | ANDA |
| 16729-483 | Atropine Sulfate .05 mg/mL Injection | Accord Healthcare, Inc., | ANDA |
| 0517-1001 | Atropine Sulfate 1 mg/mL Injection, Solution | American Regent, Inc. | ANDA |
| 0517-1004 | Atropine Sulfate .4 mg/mL Injection, Solution | American Regent, Inc. | ANDA |
| 70121-1705 | Atropine Sulfate .1 mg/mL Injection, Solution | Amneal Pharmaceuticals LLC | ANDA |
| 70121-1706 | Atropine Sulfate .1 mg/mL Injection, Solution | Amneal Pharmaceuticals LLC | ANDA |
| 42799-826 | Atropine Sulfate 10 mg/mL Solution/ Drops | Edenbridge Pharmaceuticals LLC. | ANDA |
| 0404-9802 | Atropine Sulfate .4 mg/mL Injection, Solution | Henry Schein, Inc | ANDA |
| 0404-9784 | Atropine Sulfate .1 mg/mL Injection, Solution | Henry Schein, Inc. | ANDA |
| 51662-1627 | Atropine Sulfate .4 mg/mL Injection, Solution | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1626 | Atropine Sulfate 1 mg/mL Injection, Solution | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1619 | Atropine Sulfate .4 mg/mL Injection | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1527 | Atropine Sulfate .1 mg/mL Injection | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 0641-6274 | Atropine Sulfate .4 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0641-6251 | Atropine Sulfate .4 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0641-6275 | Atropine Sulfate 1 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 76329-3340 | Atropine Sulfate .1 mg/mL Injection | International Medication Systems, Limited | ANDA |
| 70756-651 | Atropine Sulfate 10 mg/mL Solution/ Drops | Lifestar Pharma LLC | ANDA |
| 70756-653 | Atropine Sulfate 10 mg/mL Solution/ Drops | Lifestar Pharma LLC | ANDA |
| 70756-652 | Atropine Sulfate 10 mg/mL Solution/ Drops | Lifestar Pharma LLC | ANDA |
| 64253-400 | Atropine Sulfate .1 mg/mL Injection, Solution | Medefil, Inc. | ANDA |
| 71872-7341 | Atropine Sulfate .4 mg/mL Solution | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7340 | Atropine Sulfate 1 mg/mL Solution | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7316 | Atropine Sulfate .4 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7312 | Atropine Sulfate .4 mg/mL Injection, Solution | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7355 | Atropine Sulfate .4 mg/mL Solution | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7298 | Atropine Sulfate .1 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7252 | Atropine Sulfate .1 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 72603-264 | Atropine Sulfate 10 mg/mL Solution/ Drops | NorthStar RxLLC | ANDA |
| 84549-001 | Atropine Sulfate 1 mg/mL Injection, Solution | ProPharma Distribution | ANDA |
| 84549-340 | Atropine Sulfate .1 mg/mL Injection | ProPharma Distribution | ANDA |
| 84549-400 | Atropine Sulfate .1 mg/mL Injection, Solution | ProPharma Distribution | ANDA |
| 84549-631 | Atropine Sulfate .4 mg/mL Solution | ProPharma Distribution | ANDA |
| 67296-2124 | Atropine Sulfate 10 mg/mL Solution/ Drops | Redpharm Drug | ANDA |
| 70518-3120 | Atropine Sulfate .1 mg/mL Injection | REMEDYREPACK INC. | ANDA |
| 70518-4329 | Atropine Sulfate .4 mg/mL Injection | REMEDYREPACK INC. | ANDA |
| 70069-716 | Atropine Sulfate 10 mg/mL Solution/ Drops | Somerset Therapeutics, LLC | ANDA |
| 70069-631 | Atropine Sulfate .4 mg/mL Solution | Somerset Therapeutics, LLC | ANDA |
| 70069-583 | Atropine Sulfate 10 mg/mL Solution/ Drops | Somerset Therapeutics, LLC | ANDA |
| 70069-641 | Atropine Sulfate 1 mg/mL Solution | Somerset Therapeutics, LLC | ANDA |
| 70069-582 | Atropine Sulfate 10 mg/mL Solution/ Drops | Somerset Therapeutics, LLC | ANDA |
| 70069-581 | Atropine Sulfate 10 mg/mL Solution/ Drops | Somerset Therapeutics, LLC | ANDA |
| 70069-481 | Atropine Sulfate .4 mg/mL Solution | Somerset Therapeutics, LLC | ANDA |
| 0065-0817 | Atropine Sulfate 10 mg/mL Solution | Alcon Laboratories, Inc. | NDA |
| 24208-965 | Atropine Sulfate 10 mg/mL Solution | Bausch & Lomb Incorporated | NDA |
| 63323-580 | Atropine Sulfate .4 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | NDA |
| 0404-9823 | Atropine Sulfate .05 mg/mL Injection, Solution | Henry Schein, Inc. | NDA |
| 0404-9804 | Atropine Sulfate .4 mg/mL Injection, Solution | Henry Schein, Inc. | NDA |
| 51662-1289 | Atropine Sulfate .1 mg/mL Injection, Solution | HF Acquisition Co LLC, DBA HealthFirst | NDA |
| 0409-9630 | Atropine Sulfate .05 mg/mL Injection, Solution | Hospira, Inc. | NDA |
| 0409-1630 | Atropine Sulfate .1 mg/mL Injection, Solution | Hospira, Inc. | NDA |
| 71872-7002 | Atropine Sulfate .1 mg/mL Injection, Solution | Medical Purchasing Solutions, LLC | NDA |
| 84549-580 | Atropine Sulfate .4 mg/mL Injection, Solution | ProPharma Distribution | NDA |
| 70518-4188 | Atropine Sulfate .4 mg/mL Injection, Solution | REMEDYREPACK INC. | NDA |
| 82260-001 | Atropine Sulfate 10 mg/mL Solution | Bausch & Lomb Americas Inc. | NDA AUTHORIZED GENERIC |
| 24208-825 | Atropine Sulfate 10 mg/g Ointment | Bausch & Lomb Incorporated | UNAPPROVED DRUG OTHER |
| 51662-1311 | Atropine Sulfate .4 mg/mL Injection | HF Acquisition Co LLC, DBA HealthFirst | UNAPPROVED DRUG OTHER |
| 51662-1207 | Atropine Sulfate .1 mg/mL Injection, Solution | HF Acquisition Co. LLC, DBA Health First | UNAPPROVED DRUG OTHER |
| 51662-1208 | Atropine Sulfate .1 mg/mL Injection, Solution | HF Acquisition Co., LLC, DBA Health First | UNAPPROVED DRUG OTHER |
| 71872-7037 | Atropine Sulfate .4 mg/mL Injection | Medical Purchasing Solutions, LLC | UNAPPROVED DRUG OTHER |
atropine sulfate recalls
- D-0795-2026 Aug 26, 2026 · Class II · Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - D-0169-2025 Jan 8, 2025 · Class III · Terminated
Failed Impurities/Degradation Specifications - D-0235-2024 Jan 24, 2024 · Class I · Ongoing
Presence of Particulate Matter; identified as glass - D-0917-2023 Jul 19, 2023 · Class II · Terminated
Presence of Particulate Matter: Particulate matter identified as fiber.
Frequently asked questions
What is atropine sulfate used for?
Atropine Sulfate Injection is indicated for temporary blockade of severe or life‑threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. Atropine is a muscarinic antagonist indicated for temporary blockade of severe or life‑threatening muscarinic effects. ( 1 )
What are the side effects of atropine sulfate?
The following adverse reactions have been identified during post-approval use of atropine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of… See the full label for the complete list.
Who makes atropine sulfate?
atropine sulfate is listed by 26 labelers in the FDA NDC directory, including A-S Medication Solutions, Accord Healthcare Inc., Accord Healthcare, Inc.,, American Regent, Inc..
Has atropine sulfate been recalled?
The FDA enforcement database lists 4 recalls for atropine sulfate, most recently D-0795-2026 (class ii): Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde