FDA Drug Recall Tracker 2026 - Latest US Drug Recalls & Enforcement Reports

Reported	Class	Product	Recalling Firm
02 Sep 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	ACCORD HEALTHCARE, INC.
02 Sep 2026	Class II	RAMIPRIL Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).	Hikma Pharmaceuticals USA INC.
02 Sep 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	ACCORD HEALTHCARE, INC.
02 Sep 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	ACCORD HEALTHCARE, INC.
02 Sep 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	ACCORD HEALTHCARE, INC.
02 Sep 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	ACCORD HEALTHCARE, INC.
02 Sep 2026	Class II	CLOBETASOL PROPIONATE Failed content uniformity specifications.	Lupin Pharmaceuticals Inc.
02 Sep 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	ACCORD HEALTHCARE, INC.
02 Sep 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	ACCORD HEALTHCARE, INC.
02 Sep 2026	Class II	ACTHAR Presence of particulate matter: glass and stopper piece	Mallinckrodt Hospital Products Inc.
02 Sep 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	ACCORD HEALTHCARE, INC.
02 Sep 2026	Class II	Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Men… CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing	Church & Dwight Co., Inc.
02 Sep 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	ACCORD HEALTHCARE, INC.
02 Sep 2026	Class I	TYENNE Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.	Fresenius Kabi USA, LLC
02 Sep 2026	Class I	LACTATED RINGERS Presence of Particulate matter.	B BRAUN MEDICAL INC
02 Sep 2026	Not Yet Classified	Ibuprofen, 150 mg per 7.5 mL, Delivers: 7.5 mL, Conc: 20 mg… Cross Contamination with Other Products	Safecor Health, LLC
02 Sep 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	ACCORD HEALTHCARE, INC.
02 Sep 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	ACCORD HEALTHCARE, INC.
02 Sep 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	ACCORD HEALTHCARE, INC.
02 Sep 2026	Class II	PAXIL Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria	Apotex Corp.
26 Aug 2026	Class II	CYANOCOBALAMIN Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde	American Regent, Inc.
26 Aug 2026	Class II	CARBAMAZEPINE CGMP deviations: tablets with black specks.	Golden State Medical Supply Inc.
26 Aug 2026	Class II	MULTRYS Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde	American Regent, Inc.
26 Aug 2026	Class II	ACETYLCYSTEINE Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde	American Regent, Inc.
26 Aug 2026	Class I	PAPAVERINE HYDROCHLORIDE Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde	American Regent, Inc.
26 Aug 2026	Class II	ACETYLCYSTEINE Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde	American Regent, Inc.
26 Aug 2026	Class II	PEMRYDI RTU Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials	Shilpa Medicare Limited
26 Aug 2026	Class II	ATROPINE SULFATE Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde	American Regent, Inc.
26 Aug 2026	Class II	LIBTAYO Lack of Assurance of Sterility	Regeneron Pharmaceuticals Inc
26 Aug 2026	Class II	NITROGLYCERIN Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde	American Regent, Inc.
26 Aug 2026	Class II	ACAMPROSATE CALCIUM Failed Dissolution Specifications	Mylan Pharmaceuticals Inc
26 Aug 2026	Class II	PEMRYDI RTU Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials	Shilpa Medicare Limited
26 Aug 2026	Class II	NICARDIPINE HYDROCHLORIDE Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde	American Regent, Inc.
26 Aug 2026	Class II	AMINOCAPROIC ACID Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde	American Regent, Inc.
26 Aug 2026	Class II	SELENIOUS ACID Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde	American Regent, Inc.
26 Aug 2026	Class I	MORPHINE SULFATE Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.	Fresenius Kabi USA, LLC
26 Aug 2026	Class II	CARBAMAZEPINE CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing	SUN PHARMACEUTICAL INDUSTRIES INC
26 Aug 2026	Class II	CYANOCOBALAMIN Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde	American Regent, Inc.
26 Aug 2026	Class II	TRALEMENT Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde	American Regent, Inc.
19 Aug 2026	Class I	Kian Pee Wan Capsules, 30-count bottles Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.	Buy-Herbal
19 Aug 2026	Class II	SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONL… CGMP Deviations:Noted during FDA inspection	Shoolin Pharma Chem LLP
19 Aug 2026	Class II	SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Apollo Care, LLC
19 Aug 2026	Class I	Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains … Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.	Victory Medical Center Pharmacy
19 Aug 2026	Class II	SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Apollo Care, LLC
19 Aug 2026	Class II	SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose V… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Apollo Care, LLC
19 Aug 2026	Class I	OPTIRAY Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.	Liebel-Flarsheim Company LLC
19 Aug 2026	Class II	CLINDAMYCIN PALMITATE HYDROCHLORIDE Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.	Heritage Pharmaceuticals Inc
19 Aug 2026	Class II	SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 m… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Apollo Care, LLC
19 Aug 2026	Class II	SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose V… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Apollo Care, LLC
19 Aug 2026	Class II	SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Apollo Care, LLC
19 Aug 2026	Class II	CLEAR EYES MAXIMUM ITCHY EYE RELIEF Lack of assurance of sterility. The recall is due to potential contamination	Prestige Brands Holdings
19 Aug 2026	Class II	SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Ste… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Apollo Care, LLC
19 Aug 2026	Class II	SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Ste… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Apollo Care, LLC
19 Aug 2026	Class II	SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, … Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Apollo Care, LLC
19 Aug 2026	Class II	TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Pr… CGMP Deviations:Noted during FDA inspection	Shoolin Pharma Chem LLP
19 Aug 2026	Class II	TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For … CGMP Deviations:Noted during FDA inspection	Shoolin Pharma Chem LLP
19 Aug 2026	Class II	SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Apollo Care, LLC
19 Aug 2026	Class II	DIOVAN Failed Dissolution Specifications	Novartis Pharmaceuticals Corporation
19 Aug 2026	Class II	SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Ster… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material	Apollo Care, LLC
19 Aug 2026	Class I	CEFAZOLIN Presence of Particulate Matter	Baxter Healthcare Corporation
19 Aug 2026	Class II	SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only … CGMP Deviations:Noted during FDA inspection	Shoolin Pharma Chem LLP
19 Aug 2026	Class II	TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Pres… CGMP Deviations:Noted during FDA inspection	Shoolin Pharma Chem LLP
12 Aug 2026	Class II	DICYCLOMINE HYDROCHLORIDE shortfill; reports of empty capsules.	Aurobindo Pharma USA Inc
12 Aug 2026	Class I	Cyclophosphamide for Injection, USP, 2 gram/vial, One Singl… Presence of Particulate Matter; identified as stainless steel	Sunny Pharmtech Inc.
12 Aug 2026	Class III	Total Parental Nutrition - Pediatric PN Patient-Specific TP… Incorrect Product Formulation	Central Admixture Pharmacy Services Inc
12 Aug 2026	Class II	MIRABEGRON CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.	Zydus Pharmaceuticals (USA) Inc
12 Aug 2026	Class I	Cyclophosphamide for Injection, USP, 1 gram/vial, One Singl… Presence of Particulate Matter; identified as stainless steel	Sunny Pharmtech Inc.
05 Aug 2026	Class III	DABIGATRAN ETEXILATE Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity …	Ascend Laboratories, LLC
05 Aug 2026	Class III	DABIGATRAN ETEXILATE Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity …	Ascend Laboratories, LLC
05 Aug 2026	Class II	AZELAIC ACID CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) we…	Glenmark Pharmaceuticals Inc., USA
05 Aug 2026	Class II	MYCOPHENOLATE MOFETIL Presence of precipitate	MYLAN PHARMACEUTICALS INC
05 Aug 2026	Class II	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.	MICRO LABS USA INC
05 Aug 2026	Class III	DABIGATRAN ETEXILATE Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity …	Ascend Laboratories, LLC
29 Jul 2026	Class II	ROHTO Lack of Assurance of Sterility	Rohto-Mentholatum (Vietnam) Co., Ltd.
29 Jul 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	Major Pharmaceuticals
29 Jul 2026	Class II	ROHTO Lack of Assurance of Sterility	Rohto-Mentholatum (Vietnam) Co., Ltd.
29 Jul 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	Major Pharmaceuticals
29 Jul 2026	Class III	TROKENDI XR Failed Dissolution Specifications	Supernus Pharmaceuticals, Inc.
29 Jul 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	Major Pharmaceuticals
29 Jul 2026	Class II	NAROPIN Presence of Particulate Matter: Hair was found in products	Fresenius Kabi USA, LLC
29 Jul 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	Major Pharmaceuticals
29 Jul 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	Major Pharmaceuticals
29 Jul 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	Major Pharmaceuticals
29 Jul 2026	Class II	ROHTO DIGI-EYE Lack of Assurance of Sterility	Rohto-Mentholatum (Vietnam) Co., Ltd.
29 Jul 2026	Class II	XYLOCAINE Presence of Particulate Matter: Hair was found in products	Fresenius Kabi USA, LLC
29 Jul 2026	Class II	ROHTO DRY-AID Lack of Assurance of Sterility	Rohto-Mentholatum (Vietnam) Co., Ltd.
29 Jul 2026	Class III	DABIGATRAN ETEXILATE Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to …	Ascend Laboratories, LLC
29 Jul 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	Major Pharmaceuticals
29 Jul 2026	Class II	LIDOCAINE Presence of Particulate Matter: Hair was found in products	Fresenius Kabi USA, LLC
29 Jul 2026	Class II	ROHTO Lack of Assurance of Sterility	Rohto-Mentholatum (Vietnam) Co., Ltd.
29 Jul 2026	Class II	DIVALPROEX SODIUM Presence of Foreign Tablets/Capsules	Bionpharma Inc.
29 Jul 2026	Class III	LIDOLOG KIT Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan	Asclemed USA Inc.
29 Jul 2026	Class II	AMLODIPINE AND OLMESARTAN MEDOXOMIL Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications	Ascend Laboratories, LLC
29 Jul 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	Major Pharmaceuticals
29 Jul 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	Major Pharmaceuticals
29 Jul 2026	Class II	ROHTO OPTIC GLOW Lack of Assurance of Sterility	Rohto-Mentholatum (Vietnam) Co., Ltd.
29 Jul 2026	Class II	XYLOCAINE Presence of Particulate Matter: Hair was found in products	Fresenius Kabi USA, LLC
29 Jul 2026	Class II	GLYCOPYRROLATE Presence of Particulate Matter: Hair was found in product	Fresenius Kabi USA, LLC
29 Jul 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	Major Pharmaceuticals
29 Jul 2026	Class II	GLYCOPYRROLATE Failed Impurities/Degradation Specifications	Precision Dose Inc.

Source: openFDA Drug Enforcement API, U.S. Food & Drug Administration - Class I is the most serious (reasonable probability of serious harm or death), Class III the least. openFDA data is provided as-is and unvalidated. See our FDA Approvals Tracker for new drug approvals, or the EMA Approvals Tracker for the EU market.