Browse Drug Recalls
15 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 15 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 15 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 2, 2026 | Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) b... | Presence of foreign substance: the firm received complaints for a gel-like mass and black particl... | Class II | STRIDES PHARMA INC |
| Jul 9, 2025 | Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides... | Failed Dissolution Specifications. | Class II | Strides Pharma, Inc. |
| Mar 5, 2025 | Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, D... | Presence of foreign substance: Presence of Benzene. | Class II | Strides Pharma, Inc. |
| Mar 5, 2025 | Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Dist... | Presence of foreign substance: Presence of Benzene. | Class II | Strides Pharma, Inc. |
| Dec 29, 2023 | Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: St... | Failed Dissolution Specifications | Class II | Strides Pharma Inc. |
| Jun 26, 2023 | Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, ... | Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet. | Class II | Strides Pharma Inc. |
| Jul 19, 2022 | Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: St... | Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets | Class II | Strides Pharma Inc. |
| May 18, 2022 | Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Lif... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Strides Pharma Inc. |
| May 18, 2022 | Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Li... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Strides Pharma Inc. |
| May 18, 2022 | Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Lif... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Strides Pharma Inc. |
| Sep 27, 2021 | Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets... | Failed Dissolution Specifications | Class II | Strides Pharma Inc. |
| Dec 22, 2020 | NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactur... | Failed Moisture Limits | Class III | Strides Pharma Inc. |
| Aug 24, 2020 | Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (6... | Failed Dissolution Specifications | Class II | Strides Inc. |
| Feb 17, 2020 | Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count b... | Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chlor... | Class III | Strides Pharma Science Limited |
| May 9, 2017 | Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Str... | Failed Stability Specifications: Out of Specification results obtained for preservative Methylpar... | Class III | Strides 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.