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

Reported	Class	Product	Recalling Firm
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	Not Yet Classified	DABIGATRAN ETEXILATE Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Relat…	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 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 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	LEVOTHYROXINE SODIUM Subpotent Drug	Major Pharmaceuticals
29 Jul 2026	Class II	CYPROHEPTADINE HYDROCHLORIDE Presence of Precipitate: medication was crystallizing and particles floating in the bottle	Rising Pharma Holding, Inc.
29 Jul 2026	Class I	CETIRIZINE HYDROCHLORIDE Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetir…	JB Chemicals and Pharmaceuticals 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	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 DRY-AID Lack of Assurance of Sterility	Rohto-Mentholatum (Vietnam) Co., Ltd.
22 Jul 2026	Class II	CLEVIPREX Lack of Assurance of Sterility	Chiesi USA, Inc.
22 Jul 2026	Class II	QUALITY CHOICE EARWAX REMOVAL KIT SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Bell Pharmaceuticals, Inc
22 Jul 2026	Class II	CLINERE EAR WAX REMOVER SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Bell Pharmaceuticals, Inc
22 Jul 2026	Class II	LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULB SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Bell Pharmaceuticals, Inc
22 Jul 2026	Class II	FAMILY WELLNESS EARWAX REMOVAL EARWAX AND BULB SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Bell Pharmaceuticals, Inc
22 Jul 2026	Class II	CHLORAPREP ONE-STEP Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator	CareFusion 213, LLC
22 Jul 2026	Class II	CAREONE EARWAX REMOVAL DROPS SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Bell Pharmaceuticals, Inc
22 Jul 2026	Class II	NYSTATIN Subpotent Drug: Low out of specification assay results performed during long-term stability testing.	Padagis US LLC
22 Jul 2026	Class II	MEIJER EARWAX REMOVAL KIT SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Bell Pharmaceuticals, Inc
22 Jul 2026	Class II	CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AID SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Bell Pharmaceuticals, Inc
22 Jul 2026	Class II	TOPCARE EARWAX REMOVAL KIT SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Bell Pharmaceuticals, Inc
22 Jul 2026	Class II	AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Bell Pharmaceuticals, Inc
22 Jul 2026	Class II	GOOD NEIGHBOR PHARMACY EARWAX REMOVAL SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Bell Pharmaceuticals, Inc
22 Jul 2026	Class II	Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL)… SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Bell Pharmaceuticals, Inc
15 Jul 2026	Class II	METHOHEXITAL SODIUM Failed Impurities/Degradation Specifications	ONESOURCE SPECIALTY PHARMA LIMITED
15 Jul 2026	Class II	Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.7… Subpotent drug	Gasco Industrial Corp.
15 Jul 2026	Class II	Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industria… Subpotent drug	Gasco Industrial Corp.
15 Jul 2026	Class II	Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz… Subpotent drug	Gasco Industrial Corp.
15 Jul 2026	Class II	Clomiphene Citrate USP Active Pharmaceutical Ingredient (CA… cGMP deviations	Shimoga Chemicals
15 Jul 2026	Class II	Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vi… Lack of Sterility Assurance	Reliance Life Sciences Private Limited
15 Jul 2026	Class II	Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL).… Subpotent drug	Gasco Industrial Corp.
15 Jul 2026	Class II	Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gal… Subpotent drug	Gasco Industrial Corp.
15 Jul 2026	Class II	Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose … Lack of Sterility Assurance	Reliance Life Sciences Private Limited
15 Jul 2026	Class II	Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vi… Lack of Sterility Assurance	Reliance Life Sciences Private Limited
15 Jul 2026	Class II	Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose V… Lack of Sterility Assurance	Reliance Life Sciences Private Limited
15 Jul 2026	Class II	MEDLINE Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.	BioMed Laboratories, LLC.
15 Jul 2026	Class II	Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz… Subpotent drug	Gasco Industrial Corp.
15 Jul 2026	Class II	Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume:… Failed Impurities/Degradation Specifications	QuVa Pharma, Inc.
08 Jul 2026	Class II	TERPENICOL CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	Blaine Labs Inc
08 Jul 2026	Class II	CHLORAPREP ONE-STEP Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization …	CareFusion 213, LLC
08 Jul 2026	Class II	Fungal Fusion ERADICATION Solution, Antifungal & Antimicrob… CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	Blaine Labs Inc
08 Jul 2026	Class II	CHLORAPREP ONE-STEP Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization …	CareFusion 213, LLC
08 Jul 2026	Class II	GLUCAGON CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.	Lupin Pharmaceuticals Inc.
08 Jul 2026	Class II	CINACALCET cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).	Cipla USA, Inc.
08 Jul 2026	Class II	ACCUCAINE Lack of Assurance of Sterility	Asclemed USA Inc.
08 Jul 2026	Class II	CHLORAPREP ONE-STEP Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization …	CareFusion 213, LLC
08 Jul 2026	Class I	Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, pack… Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus s…	Blaine Labs Inc
08 Jul 2026	Class III	Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistami… Failed Impurities/Degradation Specifications	SUN PHARMACEUTICAL INDUSTRIES INC
08 Jul 2026	Class II	TRIPENICOL S CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	Blaine Labs Inc
08 Jul 2026	Class II	CHLORAPREP ONE-STEP Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization …	CareFusion 213, LLC
08 Jul 2026	Class II	PREDNISOLONE ACETATE Presence of Foreign Substance	Lupin Pharmaceuticals Inc.
08 Jul 2026	Class II	REVITADERM WOUND CARE CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated	Blaine Labs Inc
08 Jul 2026	Class II	CHLORAPREP ONE-STEP Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization …	CareFusion 213, LLC
08 Jul 2026	Class II	LEVOTHYROXINE SODIUM Subpotent Drug	ACCORD HEALTHCARE, INC.
08 Jul 2026	Class II	PURPREP Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization …	CareFusion 213, LLC
08 Jul 2026	Class II	CINACALCET cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).	Cipla USA, Inc.
08 Jul 2026	Class II	CINACALCET cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).	Cipla USA, Inc.
08 Jul 2026	Class II	vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (1… CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	Blaine Labs Inc
08 Jul 2026	Class II	LIDOCAINE HYDROCHLORIDE Lack of Assurance of Sterility	Asclemed USA Inc.
08 Jul 2026	Class II	IMULDOSA Lack of assurance of Sterility:	ACCORD BIOPHARMA INC
08 Jul 2026	Class II	TRIDERGEL CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated	Blaine Labs Inc
08 Jul 2026	Class II	TERPENICOL CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	Blaine Labs Inc
08 Jul 2026	Class II	CHLORAPREP ONE-STEP Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization …	CareFusion 213, LLC
08 Jul 2026	Class II	GEMCITABINE Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environm…	McKesson
08 Jul 2026	Class II	CHLORAPREP ONE-STEP Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization …	CareFusion 213, LLC
08 Jul 2026	Class II	CHLORAPREP ONE-STEP Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization …	CareFusion 213, LLC
08 Jul 2026	Class II	CHLORAPREP ONE-STEP Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization …	CareFusion 213, LLC
08 Jul 2026	Class II	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.	Lannett Company Inc.
08 Jul 2026	Class II	Synjardy XR Tablets (empagliflozin and metformin hydrochlor… CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had…	Boehringer Ingelheim Pharmaceuticals, Inc.
01 Jul 2026	Class II	LACOSAMIDE Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets…	Annora Pharma Private Limited
01 Jul 2026	Class II	CORLANOR Presence of Foreign Substance.	Amgen, Inc.
01 Jul 2026	Class II	CORLANOR Presence of Foreign Substance.	Amgen, Inc.
01 Jul 2026	Class II	CHLORAPREP ONE-STEP Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.	CareFusion 213, LLC
01 Jul 2026	Class II	FENOFIBRATE CGMP Deviations	Ajanta Pharma USA Inc
01 Jul 2026	Class II	SENSIPAR CGMP Deviations	Amgen, 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.