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Browse Drug Recalls

8 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 8 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 8 FDA drug recalls.

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DateProductReasonClassFirm
Jul 11, 2025 Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-00... CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it canno... Class II Nostrum Laboratories, Inc.
Jan 25, 2021 Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets pe... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Nostrum Laboratories Inc
Jan 4, 2021 Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets pe... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Nostrum Laboratories Inc
Oct 23, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottl... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Nostrum Laboratories Inc
Oct 23, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottl... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Nostrum Laboratories Inc
Mar 6, 2020 Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, ... CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/... Class II Nostrum Laboratories Inc
Feb 13, 2018 Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufact... Presence of Foreign Tablets/Capsules Class III Nostrum Laboratories Inc
May 23, 2016 Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY T... Failed Dissolution Specifications Class II Nostrum Laboratories, 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.