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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
Feb 14, 2020 Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 m... Labeling: Incorrect or Missing Lot and/or Expiration date. Class III AAA Pharmaceutical, Inc.
Dec 26, 2019 Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AAA Pharmaceutical, Inc.
Dec 26, 2019 Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AAA Pharmaceutical, Inc.
Jun 25, 2019 Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count U... Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration da... Class III AAA Pharmaceutical, 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.