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Browse Drug Recalls

4 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 4 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 4 FDA drug recalls.

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DateProductReasonClassFirm
Jul 15, 2021 Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne ... cGMP Deviations Class II API Solutions Inc.
Jul 15, 2021 Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendsh... cGMP Deviations Class II API Solutions Inc.
Aug 22, 2018 THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Syntec Pharma Corp
Aug 22, 2018 THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothy... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Syntec Pharma Corp

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.