Browse Drug Recalls
777 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 777 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 777 FDA drug recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 2, 2025 | Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx On... | Lack of assurance of sterility. Bacterial contamination detected in some media fill units | Class II | Amerisource Health Services LLC |
| Apr 2, 2025 | Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx o... | Lack of assurance of sterility. Bacterial contamination detected in some media fill units | Class II | Amerisource Health Services LLC |
| Mar 31, 2025 | PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL ... | Lack of Assurance of Sterility: Leaking/damaged syringes. | Class II | Denver Solutions, LLC DBA Leiters Health |
| Mar 31, 2025 | Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, ... | Lack of Assurance of Sterility: Leaking/damaged syringes. | Class II | Denver Solutions, LLC DBA Leiters Health |
| Mar 31, 2025 | Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, ... | Lack of Assurance of Sterility: Leaking/damaged syringes. | Class II | Denver Solutions, LLC DBA Leiters Health |
| Mar 31, 2025 | 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL... | Presence of Particulate Matter | Class II | B. Braun Medical Inc |
| Mar 31, 2025 | dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mc... | Lack of Assurance of Sterility: Leaking/damaged syringes. | Class II | Denver Solutions, LLC DBA Leiters Health |
| Mar 31, 2025 | Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38... | CGMP Deviations | Class II | Medisca Inc. |
| Mar 31, 2025 | Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx ... | Lack of Assurance of Sterility: Leaking/damaged syringes. | Class II | Denver Solutions, LLC DBA Leiters Health |
| Mar 26, 2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per ... | CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... | Class II | Breckenridge Pharmaceutical, Inc. |
| Mar 26, 2025 | Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsul... | CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-de... | Class II | Chattem Inc |
| 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 21, 2025 | Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manu... | Lack of Assurance of Sterility: Media fill with bacterial contamination | Class II | Somerset Therapeutics Private Limited |
| Mar 21, 2025 | Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manuf... | Lack of Assurance of Sterility: Media fill with bacterial contamination | Class II | Somerset Therapeutics Private Limited |
| Mar 21, 2025 | Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Ma... | Lack of Assurance of Sterility: Media fill with bacterial contamination | Class II | Somerset Therapeutics Private Limited |
| Mar 21, 2025 | Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Via... | Lack of Assurance of Sterility: Media fill with bacterial contamination | Class II | Somerset Therapeutics Private Limited |
| Mar 21, 2025 | Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesci... | Presence of Foreign Substance: Product complaint received for the presence of foreign material em... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Mar 21, 2025 | Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manuf... | Lack of Assurance of Sterility: Media fill with bacterial contamination | Class II | Somerset Therapeutics Private Limited |
| Mar 17, 2025 | Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactu... | Failed dissolution specifications: lower than specifications | Class II | BIOCON PHARMA INC |
| 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 | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), ... | LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium ... | Class I | Dr. Reddy's Laboratories, Inc. |
| 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 |
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.