Browse Drug Recalls

6 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6 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 6 FDA drug recalls.

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DateProductReasonClassFirm
Jan 9, 2018 Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma Inc.
Jan 9, 2018 Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Marksans Pharma 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.