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Browse Drug Recalls

15 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 15 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 15 FDA drug recalls.

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DateProductReasonClassFirm
Feb 5, 2026 acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injecti... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC
Feb 5, 2026 vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Inject... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC
Feb 5, 2026 vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride In... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC
Feb 5, 2026 ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC
Feb 5, 2026 thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection,... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Singl... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Singl... CGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single D... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Do... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Singl... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose ... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose B... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Singl... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL... cGMP violations Class II Fresenius Kabi Compounding, 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.