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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
Jul 13, 2023 Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bot... Presence of Foreign Substance: Metal embedded in a tablet. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 3, 2022 Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose via... CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 31, 2021 Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 ... Microbial Contamination of Non-Sterile Product Class II SUN PHARMACEUTICAL INDUSTRIES INC
Dec 7, 2018 Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Pa... Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained dur... Class III Sun Pharmaceutical Industries, Inc.
Jul 17, 2015 buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-... Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it... Class III Sun Pharma Global Fze
May 21, 2013 Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count u... Crystallization; crystallized nimodipine Class II Sun Pharmaceutical Industries 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.