Browse Drug Recalls
1,678 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,678 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 1,678 FDA drug recalls — Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 29, 2025 | Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, M... | Presence of a foreign substance: black hair found embedded in tablet. | Class III | Macleods Pharmaceuticals Ltd |
| May 19, 2025 | Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manuf... | Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances t... | Class III | Glenmark Pharmaceuticals Inc., USA |
| Apr 15, 2025 | HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette,... | Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was ... | Class III | OurPharma LLC |
| Mar 4, 2025 | Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, ... | Cross Contamination | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 4, 2025 | Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Un... | Failed Dissolution Specifications: Out of specification results obtained during routine stability... | Class III | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Mar 4, 2025 | Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, N... | Cross Contamination | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 24, 2025 | Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Sol... | Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product s... | Class III | Imprimis NJOF, LLC |
| Feb 24, 2025 | Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured... | Presence of foreign tablets/capsules | Class III | Kowa Pharmaceuticals America |
| Jan 17, 2025 | BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% z... | Labeling: Missing Label: The finished product potentially missing the labeling with the drug fac... | Class III | The W.S. Badger Company, Inc. |
| Jan 16, 2025 | Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufacture... | Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet | Class III | Appco Pharma LLC |
| Jan 7, 2025 | Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16... | Superpotent; sodium benzoate preservative | Class III | PAI Holdings, LLC. dba Pharmaceutical Associate... |
| Dec 19, 2024 | Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, ... | Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configur... | Class III | West-Ward Columbus Inc |
| Dec 18, 2024 | Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops,... | LABELING: LABEL MIX-UP | Class III | AvKARE |
| Dec 18, 2024 | Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant... | LABELING: LABEL MIX-UP | Class III | AvKARE |
| Dec 16, 2024 | Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufact... | Failed Impurities/Degradation Specifications | Class III | SOMERSET THERAPEUTICS LLC |
| Dec 12, 2024 | Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, M... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, In... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufacture... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma,... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactur... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactur... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufact... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Nov 22, 2024 | Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx On... | Failed Impurities/Degradation Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 14, 2024 | Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-D... | Labeling: Not Elsewhere Classified - Wrong NDC number | Class III | Zydus Pharmaceuticals (USA) Inc |
| Nov 5, 2024 | Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distribu... | Failed Impurities/Degradation Specifications; during routine stability testing for impurities. | Class III | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Oct 29, 2024 | IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. ... | Failed Tablet/Capsule Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Oct 11, 2024 | Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Man... | Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity... | Class III | Padagis US LLC |
| Sep 30, 2024 | Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only... | Defective Container: Firm received complaints of broken tube at the seal. | Class III | Glenmark Pharmaceuticals Inc., USA |
| Sep 25, 2024 | Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin,... | Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal subs... | Class III | Denison Pharmaceuticals, LLC |
| Sep 25, 2024 | Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin... | Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal subs... | Class III | Denison Pharmaceuticals, LLC |
| Aug 24, 2024 | AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed b... | Discoloration | Class III | Rubicon Research Private Limited |
| Aug 20, 2024 | Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g... | LABELING: LABEL MIX-UP. | Class III | Elevate Oral Care |
| Aug 15, 2024 | Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 sili... | Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes pac... | Class III | Biocompatibles UK, Ltd. |
| Aug 7, 2024 | Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg ... | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related i... | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Aug 1, 2024 | Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: ... | Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg with... | Class III | Amneal Pharmaceuticals, LLC |
| Jul 18, 2024 | Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid ... | Label mix-up: Carton incorrectly labeled. | Class III | Granules Consumer Health Inc. |
| Jul 2, 2024 | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufa... | Cross contamination with other products | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jul 2, 2024 | PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorba... | Defective container: potential for non-sealed pouches which can lead to product leakage. | Class III | Novel Laboratories, Inc. d.b.a Lupin Somerset |
| Jul 2, 2024 | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufa... | Cross contamination with other products | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jul 2, 2024 | Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Singl... | Cross contamination with other products. | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jul 2, 2024 | Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a)... | Cross contamination with other products. | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jun 26, 2024 | Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets ... | Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on pa... | Class III | Dr. Reddy's Laboratories, Inc. |
| Jun 25, 2024 | Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by:... | Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. | Class III | GLOBAL WIDGET LLC |
| Jun 25, 2024 | Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed b... | Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. | Class III | GLOBAL WIDGET LLC |
| Jun 25, 2024 | Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz ... | Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. | Class III | GLOBAL WIDGET LLC |
| Jun 25, 2024 | Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by... | Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. | Class III | GLOBAL WIDGET LLC |
| Jun 24, 2024 | SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, ... | Sub-potent Drug | Class III | Neilmed Pharmaceuticals Inc |
| Jun 24, 2024 | Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne ... | Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testin... | Class III | Rising Pharma Holding, Inc. |
| Jun 18, 2024 | Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple do... | Subpotent drug: out of specification results | Class III | Accord Healthcare, Inc. |
| Jun 4, 2024 | Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Redd... | Failed Impurities/Degradation Specifications: Related Substances | Class III | Dr. Reddy's Laboratories, Inc. |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.