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Browse Drug Recalls

13 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 13 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 13 FDA drug recalls.

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DateProductReasonClassFirm
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

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.