Browse Drug Recalls
142 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 142 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 142 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 30, 2025 | Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercar... | Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, ... | Class II | Glenmark Pharmaceuticals Inc., USA |
| 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 |
| Sep 17, 2025 | Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured ... | CGMP Deviations: Market complaints received for gritty texture (grainy) | Class II | Glenmark Pharmaceuticals Inc., USA |
| Sep 3, 2025 | Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl... | Failed Impurities/Degradation Specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 8, 2025 | Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manuf... | Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by ... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 7, 2025 | Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: G... | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 7, 2025 | Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462... | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 7, 2025 | Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by:... | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 6, 2025 | Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactur... | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 6, 2025 | Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured... | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... | Class II | Glenmark Pharmaceuticals Inc., USA |
| 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 |
| May 15, 2025 | Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bo... | OOS results reported for the Dissolution (by UV) test. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufact... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenm... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), ... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenm... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, R... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmar... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: G... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactur... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured ... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmar... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottl... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufact... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottl... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: G... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmar... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottl... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: ... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: ... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenma... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count pack... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactur... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactu... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmar... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, R... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactu... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenma... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Man... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b)... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured b... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: ... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b).... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
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.