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Browse Drug Recalls

12 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 12 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 12 FDA drug recalls.

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DateProductReasonClassFirm
Jan 11, 2018 Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplet... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tabl... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tab... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Dist... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplet... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 table... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tab... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 ta... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tab... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jan 11, 2018 Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tab... CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... Class II Time-Cap Laboratories, Inc.
Jun 16, 2017 Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Ma... Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contai... Class II Time-Cap 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.