Browse Drug Recalls
106 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 106 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 106 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 16, 2025 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, ... | Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the... | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx On... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx O... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx ... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx ... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Onl... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx O... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Apr 10, 2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, ... | Subpotent | Class II | ACCORD HEALTHCARE, INC. |
| Apr 10, 2025 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, M... | Subpotent | Class II | ACCORD HEALTHCARE, INC. |
| Apr 10, 2025 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, M... | Subpotent | Class II | ACCORD HEALTHCARE, INC. |
| Apr 10, 2025 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, ... | Subpotent | Class II | ACCORD HEALTHCARE, INC. |
| Nov 8, 2024 | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx O... | Subpotent drug | Class II | ACCORD HEALTHCARE, INC. |
| Oct 10, 2024 | Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-1... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | ACCORD HEALTHCARE, INC. |
| Oct 10, 2024 | Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | ACCORD HEALTHCARE, INC. |
| Oct 10, 2024 | Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | ACCORD HEALTHCARE, INC. |
| Oct 1, 2024 | Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multip... | Failed Impurities/Degradation Specifications. | Class II | ACCORD HEALTHCARE, INC. |
| Jun 18, 2024 | Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple do... | Subpotent drug: out of specification results | Class III | Accord Healthcare, Inc. |
| Jul 3, 2023 | Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multipl... | Presence of Particulate Matter: Particulate matter identified as fiber. | Class II | Accord Healthcare, Inc. |
| Jul 3, 2023 | Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured... | Presence of Particulate Matter: Particulate matter identified as fiber. | Class II | Accord Healthcare, Inc. |
| Mar 29, 2023 | Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multipl... | Sub-potent drug: assay test result below specifications at 9-month timepoint. | Class III | Accord Healthcare, Inc. |
| Mar 23, 2023 | Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Acco... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accor... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufacture... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (ND... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC ... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accor... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactu... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2023 | Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord... | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Class II | Preferred Pharmaceuticals, Inc. |
| Feb 7, 2023 | Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bott... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 1... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Acc... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-1... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, R... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 167... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufa... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactur... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, 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.