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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
Sep 16, 2025 Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only... Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. Class I IntegraDose Compounding Services LLC
Mar 22, 2024 fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, I... Lack of Assurance of Sterility: leaking bags Class II IntegraDose Compounding Services LLC
Jan 22, 2024 Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injectio... Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyon... Class II IntegraDose Compounding Services LLC
Jan 12, 2024 Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 7... Subpotent Drug Class II IntegraDose Compounding Services LLC
Sep 17, 2021 ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Prod... Lack of sterility assurance. Class II IntegraDose Compounding Services LLC
Sep 17, 2021 ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, I... Lack of sterility assurance. Class II IntegraDose Compounding Services 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.