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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
Feb 15, 2022 Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-9... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-9... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-9... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Oct 9, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, Inc.
Oct 9, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, Inc.
Oct 9, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, Inc.
Oct 9, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, Inc.
Oct 9, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, Inc.
Oct 9, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, Inc.
Jan 7, 2020 Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Appco Pharma LLC
Jan 7, 2020 Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Appco Pharma 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.