Browse Drug Recalls
1,702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,702 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 1,702 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 9, 2025 | Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | STAQ Pharma, Inc. |
| Oct 9, 2025 | Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syri... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | STAQ Pharma, Inc. |
| Sep 12, 2025 | Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured... | Tablet/Capsules Imprinted with Wrong ID | Class III | JB Chemicals and Pharmaceuticals Ltd |
| Sep 12, 2025 | Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 | Labeling: Not Elsewhere Classified | Class III | Letco Medical LLC |
| Sep 12, 2025 | Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured... | Tablet/Capsules Imprinted with Wrong ID | Class III | JB Chemicals and Pharmaceuticals Ltd |
| Sep 5, 2025 | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips wit... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Aug 28, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Failed Impurities/Degradation Specifications: | Class III | Granules Pharmaceuticals Inc. |
| Aug 25, 2025 | Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By T... | Cross Contamination with Other Products. | Class III | Consumer Product Partners, LLC |
| Aug 25, 2025 | TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distribu... | Cross Contamination with Other Products. | Class III | Consumer Product Partners, LLC |
| Aug 19, 2025 | READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile,... | Subpotent drug | Class III | Medline Industries, LP |
| Aug 5, 2025 | Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIEL... | Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/W... | Class III | Haleon US Holdings LLC |
| Jul 24, 2025 | Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET C... | Failed Stability Specifications: Out of specification results was observed in Induction Port duri... | Class III | Cipla USA, Inc. |
| Jul 9, 2025 | Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496 | Subpotent Drug | Class III | Boothwyn Pharmacy LLC |
| Jul 9, 2025 | Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution... | Sub-Potent Drug: Subpotent assay results during stability testing. | Class III | Imprimis NJOF, LLC |
| Jun 26, 2025 | Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for:... | Failed Impurity/Degradation Specifications | Class III | AvKARE |
| Jun 26, 2025 | Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for:... | Failed Impurity/Degradation Specifications | Class III | AvKARE |
| Jun 16, 2025 | Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded p... | Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot n... | Class III | Qualgen, LLC |
| Jun 11, 2025 | Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Phar... | Failed Impurities/Degradation Specifications. | Class III | Orient Pharma Co., Ltd. Yunlin Plant |
| Jun 11, 2025 | Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for:... | Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle. | Class III | Macleods Pharmaceuticals Ltd |
| Jun 11, 2025 | Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Phar... | Failed Impurities/Degradation Specifications. | Class III | Orient Pharma Co., Ltd. Yunlin Plant |
| 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. |
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.