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Browse Drug Recalls

12 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 12 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 12 FDA drug recalls.

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DateProductReasonClassFirm
Aug 21, 2018 Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central D... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Cen... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central ... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 m... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Cen... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 m... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central ... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 m... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Cent... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.
Aug 21, 2018 Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multi... Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... Class II Auro Pharmacies, Inc.

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.