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Browse Drug Recalls

23 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 23 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 23 FDA drug recalls.

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DateProductReasonClassFirm
Apr 15, 2025 FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, ... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe,... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Ap... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, ... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe,... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only,... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Ap... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, A... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, ... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, ... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, ... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, A... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, A... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL ... Lack of Assurance of Sterility Class II Apollo Care, LLC
Feb 8, 2023 Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0... Lack of assurance of sterility: Suspected microbial growth present on external label packaging. Class II Apollo Care
Oct 28, 2021 VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intraveno... Crystallization: Product appears to be turbid. Class II Apollo Care
Mar 7, 2018 Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOc... Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... Class II Apollo Care
Mar 7, 2018 Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APO... Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... Class II Apollo Care
Feb 15, 2018 Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOL... Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... Class II Apollo Care
Feb 15, 2018 Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOc... Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... Class II Apollo Care

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.