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Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

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DateProductReasonClassFirm
Dec 14, 2020 Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use On... cGMP deviations: Vials may not be sealed correctly affecting sterility. Class II CIPLA
Dec 8, 2020 Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: ... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only,... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use O... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: ... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use O... CGMP Deviations Class II Shilpa Medicare Limited

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.