Latest FDA drug recalls
The newest drug recalls published in the FDA enforcement report. Class I is the most serious (reasonable probability of serious harm), Class III the least.
- fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC,… Sep 16, 2026 · Not Yet Classified · OurPharma LLC · Ongoing
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026). - Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016,… Sep 16, 2026 · Class I · Baxter Healthcare Corporation · Ongoing
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution. - FLUPHENAZINE HYDROCHLORIDE Sep 16, 2026 · Class III · Ajanta Pharma USA Inc · Ongoing
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent. - Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use… Sep 16, 2026 · Class III · ImprimisRx NJ LLC · Ongoing
Subpotent Drug - Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl… Sep 9, 2026 · Class I · OPTIMAL BALANCE PHARMACY · Ongoing
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. - SODIUM CHLORIDE Sep 9, 2026 · Class I · Baxter Healthcare Corporation · Ongoing
Presence of particulate matter: Particulates identified as fiberglass - PRASUGREL Sep 9, 2026 · Class II · Golden State Medical Supply Inc. · Ongoing
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution - BUPRENORPHINE Sep 9, 2026 · Class III · American Health Packaging · Ongoing
Labeling: Label Mix-up - PRASUGREL Sep 9, 2026 · Class II · Mylan Pharmaceuticals Inc · Ongoing
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria - REVCOVI Sep 9, 2026 · Class III · Chiesi USA, Inc. · Ongoing
Failed Stability Specifications: Out of specification stability result for the protein concentration profile. - CHLORHEXIDINE GLUCONATE Sep 9, 2026 · Class II · Sage Products, LLC · Ongoing
Cross Contamination with Other Products - TRAZODONE HYDROCHLORIDE Sep 9, 2026 · Class II · Teva Pharmaceuticals USA, Inc · Ongoing
Presence of Foreign Tablets/Capsules - Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent… Sep 9, 2026 · Class III · Supernus Pharmaceuticals, Inc. · Ongoing
Failed dissolution specifications. - MYCOPHENOLATE MOFETIL Sep 9, 2026 · Class II · Mylan Pharmaceuticals Inc · Ongoing
Failed Dissolution Specifications - Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil… Sep 9, 2026 · Class II · Lexia LLC · Ongoing
CGMP Deviations: Potential contamination of raw material - Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2… Sep 9, 2026 · Class II · Lexia LLC · Ongoing
CGMP Deviations: Potential contamination of raw material - THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml… Sep 9, 2026 · Class II · Allies Group Inc. · Ongoing
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. - THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml… Sep 9, 2026 · Class II · Allies Group Inc. · Ongoing
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. - THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml -… Sep 9, 2026 · Class II · Allies Group Inc. · Ongoing
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. - THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML… Sep 9, 2026 · Class II · Allies Group Inc. · Ongoing
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. - DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE Sep 9, 2026 · Class III · Bionpharma Inc. · Ongoing
Presence of Foreign Tablets/Capsules - DAPTOMYCIN IN SODIUM CHLORIDE Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - VANCOMYCIN HYDROCHLORIDE Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - VASOPRESSIN IN 0.9% SODIUM CHLORIDE Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - CLINDAMYCIN PHOSPHATE Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - CLINDAMYCIN PHOSPHATE Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - CLINDAMYCIN PHOSPHATE Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - CLINDAMYCIN PHOSPHATE Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - NEXTERONE Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - CARDENE IV Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - PANTOPRAZOLE SODIUM Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - VASOPRESSIN IN 0.9% SODIUM CHLORIDE Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100… Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - FAMOTIDINE Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - CLINDAMYCIN PHOSPHATE Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - DAPTOMYCIN IN SODIUM CHLORIDE Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - MYXREDLIN Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - VANCOMYCIN HYDROCHLORIDE Sep 9, 2026 · Class II · Baxter Healthcare Corporation · Ongoing
CGMP Deviations - Ibuprofen, 150 mg per 7.5 mL, Delivers: 7.5 mL, Conc: 20 mg/mL, Oral Suspension, 12mL Oral Syringes, Berry… Sep 2, 2026 · Not Yet Classified · Safecor Health, LLC · Ongoing
Cross Contamination with Other Products - LACTATED RINGERS Sep 2, 2026 · Class I · B BRAUN MEDICAL INC · Ongoing
Presence of Particulate matter. - RAMIPRIL Sep 2, 2026 · Class II · Hikma Pharmaceuticals USA INC. · Ongoing
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). - TYENNE Sep 2, 2026 · Class I · Fresenius Kabi USA, LLC · Ongoing
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. - Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex… Sep 2, 2026 · Class II · Apotex Corp. · Ongoing
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria - ACTHAR Sep 2, 2026 · Class II · Mallinckrodt Hospital Products Inc. · Ongoing
Presence of particulate matter: glass and stopper piece - Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton,… Sep 2, 2026 · Class II · Church & Dwight Co., Inc. · Ongoing
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing - CLOBETASOL PROPIONATE Sep 2, 2026 · Class II · Lupin Pharmaceuticals Inc. · Ongoing
Failed content uniformity specifications. - LEVOTHYROXINE SODIUM Sep 2, 2026 · Class II · ACCORD HEALTHCARE, INC. · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Sep 2, 2026 · Class II · ACCORD HEALTHCARE, INC. · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Sep 2, 2026 · Class II · ACCORD HEALTHCARE, INC. · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Sep 2, 2026 · Class II · ACCORD HEALTHCARE, INC. · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Sep 2, 2026 · Class II · ACCORD HEALTHCARE, INC. · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Sep 2, 2026 · Class II · ACCORD HEALTHCARE, INC. · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Sep 2, 2026 · Class II · ACCORD HEALTHCARE, INC. · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Sep 2, 2026 · Class II · ACCORD HEALTHCARE, INC. · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Sep 2, 2026 · Class II · ACCORD HEALTHCARE, INC. · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Sep 2, 2026 · Class II · ACCORD HEALTHCARE, INC. · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Sep 2, 2026 · Class II · ACCORD HEALTHCARE, INC. · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Sep 2, 2026 · Class II · ACCORD HEALTHCARE, INC. · Ongoing
Subpotent Drug - NICARDIPINE HYDROCHLORIDE Aug 26, 2026 · Class II · American Regent, Inc. · Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - TRALEMENT Aug 26, 2026 · Class II · American Regent, Inc. · Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - PAPAVERINE HYDROCHLORIDE Aug 26, 2026 · Class I · American Regent, Inc. · Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde - MULTRYS Aug 26, 2026 · Class II · American Regent, Inc. · Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - SELENIOUS ACID Aug 26, 2026 · Class II · American Regent, Inc. · Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - ACETYLCYSTEINE Aug 26, 2026 · Class II · American Regent, Inc. · Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - ACETYLCYSTEINE Aug 26, 2026 · Class II · American Regent, Inc. · Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - ATROPINE SULFATE Aug 26, 2026 · Class II · American Regent, Inc. · Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - AMINOCAPROIC ACID Aug 26, 2026 · Class II · American Regent, Inc. · Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - CYANOCOBALAMIN Aug 26, 2026 · Class II · American Regent, Inc. · Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - CYANOCOBALAMIN Aug 26, 2026 · Class II · American Regent, Inc. · Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - NITROGLYCERIN Aug 26, 2026 · Class II · American Regent, Inc. · Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - MORPHINE SULFATE Aug 26, 2026 · Class I · Fresenius Kabi USA, LLC · Ongoing
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. - ACAMPROSATE CALCIUM Aug 26, 2026 · Class II · Mylan Pharmaceuticals Inc · Ongoing
Failed Dissolution Specifications - CARBAMAZEPINE Aug 26, 2026 · Class II · Golden State Medical Supply Inc. · Ongoing
CGMP deviations: tablets with black specks. - Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical… Aug 26, 2026 · Class II · SUN PHARMACEUTICAL INDUSTRIES INC · Ongoing
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing - LIBTAYO Aug 26, 2026 · Class II · Regeneron Pharmaceuticals Inc · Ongoing
Lack of Assurance of Sterility - PEMRYDI RTU Aug 26, 2026 · Class II · Shilpa Medicare Limited · Ongoing
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials - PEMRYDI RTU Aug 26, 2026 · Class II · Shilpa Medicare Limited · Ongoing
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials - Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY… Aug 19, 2026 · Class I · Baxter Healthcare Corporation · Ongoing
Presence of Particulate Matter - OPTIRAY Aug 19, 2026 · Class I · Liebel-Flarsheim Company LLC · Ongoing
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. - Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl… Aug 19, 2026 · Class I · Victory Medical Center Pharmacy · Ongoing
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. - Kian Pee Wan Capsules, 30-count bottles Aug 19, 2026 · Class I · Buy-Herbal · Ongoing
Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine. - CLINDAMYCIN PALMITATE HYDROCHLORIDE Aug 19, 2026 · Class II · Heritage Pharmaceuticals Inc · Ongoing
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. - CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products… Aug 19, 2026 · Class II · Prestige Brands Holdings · Ongoing
Lack of assurance of sterility. The recall is due to potential contamination - SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin… Aug 19, 2026 · Class II · Shoolin Pharma Chem LLP · Ongoing
CGMP Deviations:Noted during FDA inspection - TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem… Aug 19, 2026 · Class II · Shoolin Pharma Chem LLP · Ongoing
CGMP Deviations:Noted during FDA inspection - TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma… Aug 19, 2026 · Class II · Shoolin Pharma Chem LLP · Ongoing
CGMP Deviations:Noted during FDA inspection - TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem… Aug 19, 2026 · Class II · Shoolin Pharma Chem LLP · Ongoing
CGMP Deviations:Noted during FDA inspection - SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin… Aug 19, 2026 · Class II · Shoolin Pharma Chem LLP · Ongoing
CGMP Deviations:Noted during FDA inspection - SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous… Aug 19, 2026 · Class II · Apollo Care, LLC · Ongoing
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous… Aug 19, 2026 · Class II · Apollo Care, LLC · Ongoing
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For… Aug 19, 2026 · Class II · Apollo Care, LLC · Ongoing
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous… Aug 19, 2026 · Class II · Apollo Care, LLC · Ongoing
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For… Aug 19, 2026 · Class II · Apollo Care, LLC · Ongoing
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO… Aug 19, 2026 · Class II · Apollo Care, LLC · Ongoing
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO… Aug 19, 2026 · Class II · Apollo Care, LLC · Ongoing
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO… Aug 19, 2026 · Class II · Apollo Care, LLC · Ongoing
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only,… Aug 19, 2026 · Class II · Apollo Care, LLC · Ongoing
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only,… Aug 19, 2026 · Class II · Apollo Care, LLC · Ongoing
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO… Aug 19, 2026 · Class II · Apollo Care, LLC · Ongoing
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - DIOVAN Aug 19, 2026 · Class II · Novartis Pharmaceuticals Corporation · Ongoing
Failed Dissolution Specifications - MIRABEGRON Aug 12, 2026 · Class II · Zydus Pharmaceuticals (USA) Inc · Ongoing
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. - Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove… Aug 12, 2026 · Class I · Sunny Pharmtech Inc. · Ongoing
Presence of Particulate Matter; identified as stainless steel - Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove… Aug 12, 2026 · Class I · Sunny Pharmtech Inc. · Ongoing
Presence of Particulate Matter; identified as stainless steel - Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8… Aug 12, 2026 · Class III · Central Admixture Pharmacy Services Inc · Ongoing
Incorrect Product Formulation - DICYCLOMINE HYDROCHLORIDE Aug 12, 2026 · Class II · Aurobindo Pharma USA Inc · Ongoing
shortfill; reports of empty capsules. - DABIGATRAN ETEXILATE Aug 5, 2026 · Class III · Ascend Laboratories, LLC · Ongoing
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability - DABIGATRAN ETEXILATE Aug 5, 2026 · Class III · Ascend Laboratories, LLC · Ongoing
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability - DABIGATRAN ETEXILATE Aug 5, 2026 · Class III · Ascend Laboratories, LLC · Ongoing
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability - MYCOPHENOLATE MOFETIL Aug 5, 2026 · Class II · MYLAN PHARMACEUTICALS INC · Ongoing
Presence of precipitate - AZELAIC ACID Aug 5, 2026 · Class II · Glenmark Pharmaceuticals Inc., USA · Ongoing
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. - DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION Aug 5, 2026 · Class II · MICRO LABS USA INC · Ongoing
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. - Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent… Jul 29, 2026 · Class III · Supernus Pharmaceuticals, Inc. · Ongoing
Failed Dissolution Specifications - DIVALPROEX SODIUM Jul 29, 2026 · Class II · Bionpharma Inc. · Ongoing
Presence of Foreign Tablets/Capsules - GLYCOPYRROLATE Jul 29, 2026 · Class II · Precision Dose Inc. · Ongoing
Failed Impurities/Degradation Specifications - DABIGATRAN ETEXILATE Jul 29, 2026 · Class III · Ascend Laboratories, LLC · Ongoing
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month… - DABIGATRAN ETEXILATE Jul 29, 2026 · Class III · Ascend Laboratories, LLC · Ongoing
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month… - CETIRIZINE HYDROCHLORIDE Jul 29, 2026 · Class I · JB Chemicals and Pharmaceuticals Ltd · Ongoing
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine. - XYLOCAINE Jul 29, 2026 · Class II · Fresenius Kabi USA, LLC · Ongoing
Presence of Particulate Matter: Hair was found in products - XYLOCAINE Jul 29, 2026 · Class II · Fresenius Kabi USA, LLC · Ongoing
Presence of Particulate Matter: Hair was found in products - NAROPIN Jul 29, 2026 · Class II · Fresenius Kabi USA, LLC · Ongoing
Presence of Particulate Matter: Hair was found in products - LIDOCAINE Jul 29, 2026 · Class II · Fresenius Kabi USA, LLC · Ongoing
Presence of Particulate Matter: Hair was found in products - GLYCOPYRROLATE Jul 29, 2026 · Class II · Fresenius Kabi USA, LLC · Ongoing
Presence of Particulate Matter: Hair was found in product - CYPROHEPTADINE HYDROCHLORIDE Jul 29, 2026 · Class II · Rising Pharma Holding, Inc. · Ongoing
Presence of Precipitate: medication was crystallizing and particles floating in the bottle - ROHTO Jul 29, 2026 · Class II · Rohto-Mentholatum (Vietnam) Co., Ltd. · Ongoing
Lack of Assurance of Sterility - ROHTO DRY-AID Jul 29, 2026 · Class II · Rohto-Mentholatum (Vietnam) Co., Ltd. · Ongoing
Lack of Assurance of Sterility - ROHTO DRY-AID Jul 29, 2026 · Class II · Rohto-Mentholatum (Vietnam) Co., Ltd. · Ongoing
Lack of Assurance of Sterility - ROHTO DIGI-EYE Jul 29, 2026 · Class II · Rohto-Mentholatum (Vietnam) Co., Ltd. · Ongoing
Lack of Assurance of Sterility - ROHTO OPTIC GLOW Jul 29, 2026 · Class II · Rohto-Mentholatum (Vietnam) Co., Ltd. · Ongoing
Lack of Assurance of Sterility - ROHTO Jul 29, 2026 · Class II · Rohto-Mentholatum (Vietnam) Co., Ltd. · Ongoing
Lack of Assurance of Sterility - ROHTO Jul 29, 2026 · Class II · Rohto-Mentholatum (Vietnam) Co., Ltd. · Ongoing
Lack of Assurance of Sterility - ROHTO Jul 29, 2026 · Class II · Rohto-Mentholatum (Vietnam) Co., Ltd. · Ongoing
Lack of Assurance of Sterility - LIDOLOG KIT Jul 29, 2026 · Class III · Asclemed USA Inc. · Ongoing
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan - AMLODIPINE AND OLMESARTAN MEDOXOMIL Jul 29, 2026 · Class II · Ascend Laboratories, LLC · Ongoing
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications - LEVOTHYROXINE SODIUM Jul 29, 2026 · Class II · Major Pharmaceuticals · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Jul 29, 2026 · Class II · Major Pharmaceuticals · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Jul 29, 2026 · Class II · Major Pharmaceuticals · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Jul 29, 2026 · Class II · Major Pharmaceuticals · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Jul 29, 2026 · Class II · Major Pharmaceuticals · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Jul 29, 2026 · Class II · Major Pharmaceuticals · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Jul 29, 2026 · Class II · Major Pharmaceuticals · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Jul 29, 2026 · Class II · Major Pharmaceuticals · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Jul 29, 2026 · Class II · Major Pharmaceuticals · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Jul 29, 2026 · Class II · Major Pharmaceuticals · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Jul 29, 2026 · Class II · Major Pharmaceuticals · Ongoing
Subpotent Drug - LEVOTHYROXINE SODIUM Jul 29, 2026 · Class II · Major Pharmaceuticals · Ongoing
Subpotent Drug - CHLORAPREP ONE-STEP Jul 22, 2026 · Class II · CareFusion 213, LLC · Ongoing
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator - CLEVIPREX Jul 22, 2026 · Class II · Chiesi USA, Inc. · Ongoing
Lack of Assurance of Sterility - CAREONE EARWAX REMOVAL DROPS Jul 22, 2026 · Class II · Bell Pharmaceuticals, Inc · Ongoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). - MEIJER EARWAX REMOVAL KIT Jul 22, 2026 · Class II · Bell Pharmaceuticals, Inc · Ongoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). - Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson… Jul 22, 2026 · Class II · Bell Pharmaceuticals, Inc · Ongoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). - LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB Jul 22, 2026 · Class II · Bell Pharmaceuticals, Inc · Ongoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). - GOOD NEIGHBOR PHARMACY EARWAX REMOVAL Jul 22, 2026 · Class II · Bell Pharmaceuticals, Inc · Ongoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). - FAMILY WELLNESS EARWAX REMOVAL EARWAX AND BULB Jul 22, 2026 · Class II · Bell Pharmaceuticals, Inc · Ongoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). - AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM Jul 22, 2026 · Class II · Bell Pharmaceuticals, Inc · Ongoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). - TOPCARE EARWAX REMOVAL KIT Jul 22, 2026 · Class II · Bell Pharmaceuticals, Inc · Ongoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). - QUALITY CHOICE EARWAX REMOVAL KIT Jul 22, 2026 · Class II · Bell Pharmaceuticals, Inc · Ongoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). - CLINERE EAR WAX REMOVER Jul 22, 2026 · Class II · Bell Pharmaceuticals, Inc · Ongoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). - CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AID Jul 22, 2026 · Class II · Bell Pharmaceuticals, Inc · Ongoing
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). - NYSTATIN Jul 22, 2026 · Class II · Padagis US LLC · Ongoing
Subpotent Drug: Low out of specification assay results performed during long-term stability testing. - Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC… Jul 15, 2026 · Class II · Shimoga Chemicals · Ongoing
cGMP deviations - Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous… Jul 15, 2026 · Class II · Reliance Life Sciences Private Limited · Ongoing
Lack of Sterility Assurance - Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use,… Jul 15, 2026 · Class II · Reliance Life Sciences Private Limited · Ongoing
Lack of Sterility Assurance - Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, … Jul 15, 2026 · Class II · Reliance Life Sciences Private Limited · Ongoing
Lack of Sterility Assurance - Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, … Jul 15, 2026 · Class II · Reliance Life Sciences Private Limited · Ongoing
Lack of Sterility Assurance - Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan,… Jul 15, 2026 · Class II · Gasco Industrial Corp. · Ongoing
Subpotent drug - Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan,… Jul 15, 2026 · Class II · Gasco Industrial Corp. · Ongoing
Subpotent drug - Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San… Jul 15, 2026 · Class II · Gasco Industrial Corp. · Ongoing
Subpotent drug - Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302… Jul 15, 2026 · Class II · Gasco Industrial Corp. · Ongoing
Subpotent drug - Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO… Jul 15, 2026 · Class II · Gasco Industrial Corp. · Ongoing
Subpotent drug - Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box… Jul 15, 2026 · Class II · Gasco Industrial Corp. · Ongoing
Subpotent drug - Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma,… Jul 15, 2026 · Class II · QuVa Pharma, Inc. · Ongoing
Failed Impurities/Degradation Specifications - MEDLINE Jul 15, 2026 · Class II · BioMed Laboratories, LLC. · Ongoing
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. - METHOHEXITAL SODIUM Jul 15, 2026 · Class II · ONESOURCE SPECIALTY PHARMA LIMITED · Ongoing
Failed Impurities/Degradation Specifications - GLUCAGON Jul 8, 2026 · Class II · Lupin Pharmaceuticals Inc. · Ongoing
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing. - GEMCITABINE Jul 8, 2026 · Class II · McKesson · Ongoing
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment. - REVITADERM WOUND CARE Jul 8, 2026 · Class II · Blaine Labs Inc · Ongoing
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated - Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion… Jul 8, 2026 · Class II · Blaine Labs Inc · Ongoing
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry - TERPENICOL Jul 8, 2026 · Class II · Blaine Labs Inc · Ongoing
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry - vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc.,… Jul 8, 2026 · Class II · Blaine Labs Inc · Ongoing
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry - TERPENICOL Jul 8, 2026 · Class II · Blaine Labs Inc · Ongoing
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry - TRIPENICOL S Jul 8, 2026 · Class II · Blaine Labs Inc · Ongoing
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry - TRIDERGEL Jul 8, 2026 · Class II · Blaine Labs Inc · Ongoing
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated - Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist… Jul 8, 2026 · Class I · Blaine Labs Inc · Ongoing
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp - CINACALCET Jul 8, 2026 · Class II · Cipla USA, Inc. · Ongoing
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). - CINACALCET Jul 8, 2026 · Class II · Cipla USA, Inc. · Ongoing
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). - CINACALCET Jul 8, 2026 · Class II · Cipla USA, Inc. · Ongoing
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). - DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE… Jul 8, 2026 · Class II · Lannett Company Inc. · Ongoing
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules. - LIDOCAINE HYDROCHLORIDE Jul 8, 2026 · Class II · Asclemed USA Inc. · Ongoing
Lack of Assurance of Sterility - ACCUCAINE Jul 8, 2026 · Class II · Asclemed USA Inc. · Ongoing
Lack of Assurance of Sterility - Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60… Jul 8, 2026 · Class II · Boehringer Ingelheim Pharmaceuticals, Inc. · Ongoing
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product. - LEVOTHYROXINE SODIUM Jul 8, 2026 · Class II · ACCORD HEALTHCARE, INC. · Ongoing
Subpotent Drug - PREDNISOLONE ACETATE Jul 8, 2026 · Class II · Lupin Pharmaceuticals Inc. · Ongoing
Presence of Foreign Substance - Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm… Jul 8, 2026 · Class III · SUN PHARMACEUTICAL INDUSTRIES INC · Ongoing
Failed Impurities/Degradation Specifications - IMULDOSA Jul 8, 2026 · Class II · ACCORD BIOPHARMA INC · Ongoing
Lack of assurance of Sterility: - CHLORAPREP ONE-STEP Jul 8, 2026 · Class II · CareFusion 213, LLC · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - CHLORAPREP ONE-STEP Jul 8, 2026 · Class II · CareFusion 213, LLC · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - CHLORAPREP ONE-STEP Jul 8, 2026 · Class II · CareFusion 213, LLC · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - CHLORAPREP ONE-STEP Jul 8, 2026 · Class II · CareFusion 213, LLC · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - CHLORAPREP ONE-STEP Jul 8, 2026 · Class II · CareFusion 213, LLC · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - CHLORAPREP ONE-STEP Jul 8, 2026 · Class II · CareFusion 213, LLC · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended…