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Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

Clear
DateProductReasonClassFirm
Feb 6, 2025 Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical U... Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethan... Class II Padagis US LLC
Oct 11, 2024 Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Man... Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity... Class III Padagis US LLC
Nov 1, 2023 Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, R... Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules Class II Padagis US LLC
Sep 28, 2023 Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pr... Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product r... Class II Padagis US LLC
Feb 21, 2023 Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 f... Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Stan... Class III Padagis US LLC
Aug 17, 2022 Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By ... CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of ef... Class II Padagis US LLC
Dec 27, 2021 Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bott... Defective Delivery System Class II Padagis US LLC

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.