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 |
|---|---|---|---|---|
| Jun 3, 2026 | Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured ... | Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetac... | Class III | Amneal Pharmaceuticals, LLC |
| Jun 2, 2026 | hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx... | Presence of foreign substance | Class III | ANI Pharmaceuticals, Inc. |
| Jun 1, 2026 | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets pe... | Failed Impurities/Degradation Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 1, 2026 | Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bo... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Sandoz Inc |
| May 18, 2026 | Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose ... | Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan | Class III | Eugia US LLC |
| May 18, 2026 | PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Ste... | Failed Stability Specifications | Class III | AbbVie Inc. |
| May 14, 2026 | Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius... | Failed Impurities/Degradations Specifications | Class III | Fresenius Kabi USA, LLC |
| May 14, 2026 | Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distribu... | Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, ex... | Class III | AVEVA Drug Delivery Systems, Inc. |
| May 4, 2026 | Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials,... | Failed Impurities/Degradation Specifications | Class III | Sagent Pharmaceuticals |
| May 1, 2026 | Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per c... | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Class III | Amerisource Health Services LLC |
| May 1, 2026 | Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per ca... | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Class III | Amerisource Health Services LLC |
| Apr 27, 2026 | Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: L... | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Class III | Golden State Medical Supply Inc. |
| Apr 27, 2026 | Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lan... | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Class III | Golden State Medical Supply Inc. |
| Apr 24, 2026 | Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lann... | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Class III | Lannett Company Inc. |
| Apr 16, 2026 | Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, Fo... | Labeling: Missing Label | Class III | American Regent, Inc. |
| Apr 14, 2026 | Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufac... | Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is ... | Class III | Premier Dental Products Co |
| Apr 13, 2026 | busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufa... | Subpotent drug | Class III | Unichem Pharmaceuticals USA Inc. |
| Apr 7, 2026 | Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride... | Failed PH Specifications | Class III | Water-Jel Technologies, LLC |
| Mar 31, 2026 | Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmace... | Subpotent drug | Class III | Avantor Performance Materials LLC |
| Mar 18, 2026 | Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz n... | Subpotent Drug | Class III | Island Kinetics, Inc. d.b.a. CoValence Laborato... |
| Mar 18, 2026 | Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per j... | Subpotent Drug | Class III | Island Kinetics, Inc. d.b.a. CoValence Laborato... |
| Mar 18, 2026 | Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo... | Subpotent Drug | Class III | Island Kinetics, Inc. d.b.a. CoValence Laborato... |
| Feb 19, 2026 | Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 e... | Failed Tablet/Capsule Specifications | Class III | Radnostix |
| Feb 18, 2026 | Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufac... | Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... | Class III | Cipla USA, Inc. |
| Feb 18, 2026 | Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufac... | Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... | Class III | Cipla USA, Inc. |
| Feb 12, 2026 | Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1... | Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 ... | Class III | Slate Run Pharmaceuticals |
| Feb 3, 2026 | Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactur... | Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin... | Class III | Annora Pharma Private Limited |
| Jan 21, 2026 | Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed b... | Tablets/Capsules Imprinted with Wrong ID | Class III | Unichem Pharmaceuticals USA Inc. |
| Dec 30, 2025 | Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, R... | Failed Impurities/Degradation Specifications: Out of specification result was obtained for the kn... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Dec 26, 2025 | parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and ex... | Class III | Haleon US Holdings LLC |
| Dec 22, 2025 | Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: D... | Failed PH Specifications | Class III | Cipla USA, Inc. |
| Dec 19, 2025 | traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufact... | Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on ... | Class III | Zydus Pharmaceuticals (USA) Inc |
| Dec 16, 2025 | Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, M... | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the s... | Class III | Alembic Pharmaceuticals Limited |
| Dec 15, 2025 | Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactur... | Failed Impurities/Degradation Specifications | Class III | NOVADOZ PHARMACEUTICALS LLC |
| Nov 26, 2025 | Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applica... | Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Nov 26, 2025 | Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-... | Subpotent product:out of specification assay results observed during long term stability testing. | Class III | SOMERSET THERAPEUTICS LLC |
| Nov 26, 2025 | Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single... | Subpotent product:out of specification assay results observed during long term stability testing. | Class III | SOMERSET THERAPEUTICS LLC |
| Nov 26, 2025 | Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, F... | Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle ... | Class III | Winder Laboratories, LLC |
| Nov 26, 2025 | Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Mult... | Subpotent product:out of specification assay results observed during long term stability testing. | Class III | SOMERSET THERAPEUTICS LLC |
| Nov 21, 2025 | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, pac... | Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ... | Class III | Glenmark Pharmaceuticals Inc., USA |
| Nov 18, 2025 | Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Phar... | Cross Contamination with Other Products | Class III | Glenmark Pharmaceuticals Inc., USA |
| Nov 11, 2025 | Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Labor... | Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lo... | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 7, 2025 | Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dos... | Defective Container - A defect in the side-seal which allows leakage of product. | Class III | Teva Pharmaceuticals USA, Inc |
| Oct 20, 2025 | Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emu... | Subpotent Drug | Class III | Imprimis NJOF, LLC |
| Oct 10, 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. |
| Oct 10, 2025 | Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx on... | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the s... | Class III | Alembic Pharmaceuticals Limited |
| Oct 10, 2025 | Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips w... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| Oct 10, 2025 | Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips ... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| Oct 10, 2025 | Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips w... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| Oct 9, 2025 | FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 5... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | STAQ Pharma, 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.