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Browse Drug Recalls

14 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14 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 14 FDA drug recalls.

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DateProductReasonClassFirm
Oct 15, 2025 Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcuta... Lack of Assurance of Sterility Class II ProRx LLC
Oct 15, 2025 Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutan... Lack of Assurance of Sterility Class II ProRx LLC
Oct 15, 2025 Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutan... Lack of Assurance of Sterility Class II ProRx LLC
Oct 15, 2025 Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcu... Lack of Assurance of Sterility Class II ProRx LLC
Oct 15, 2025 Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcuta... Lack of Assurance of Sterility Class II ProRx LLC
Oct 15, 2025 Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcu... Lack of Assurance of Sterility Class II ProRx LLC
Oct 15, 2025 Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcut... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: P... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: P... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Com... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vi... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass ... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, C... Lack of Assurance of Sterility Class II ProRx LLC

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.