Browse Drug Recalls
3,430 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,430 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 3,430 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 24, 2025 | Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repack... | CGMP Deviations | Class II | RemedyRepack Inc. |
| Mar 24, 2025 | Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 i... | cGMP Deviations: Received notification from their supplier requesting they perform a recall due t... | Class II | Amerisource Health Services LLC |
| 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 |
| Mar 13, 2025 | Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manuf... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufa... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 12, 2025 | In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spec... | cGMP deviations | Class II | KABANA SKIN CARE |
| Mar 12, 2025 | B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Z... | cGMP deviations | Class II | KABANA SKIN CARE |
| Mar 12, 2025 | Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Z... | cGMP deviations | Class II | KABANA SKIN CARE |
| Mar 12, 2025 | GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Su... | cGMP deviations | Class II | KABANA SKIN CARE |
| Mar 11, 2025 | chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bo... | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended in... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 7, 2025 | Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 6... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... | Class II | Direct Rx |
| Mar 7, 2025 | Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: ... | CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. | Class II | Slate Run Pharmaceuticals |
| Mar 7, 2025 | Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: ... | CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. | Class II | Slate Run Pharmaceuticals |
| Mar 7, 2025 | Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distribu... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... | Class II | Direct Rx |
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.