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Browse Drug Recalls

48 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 48 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 48 FDA drug recalls.

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DateProductReasonClassFirm
Oct 16, 2015 Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 Mc... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs,... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 M.I.C Injection (Preserved), 25/50/25mg/mL, 50mL vial, Rx only, Downing Labs,... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Vitamin D3 Injectable, 10,000 U/mL, 10mL vial, Rx only, Downing Labs, LLC 400... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Hydroxocobalamin Injection (Buffered) 1mg/mL, 30mL vial, Rx only, Downing Lab... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 Mc... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Magnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial, Rx only, Downin... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30m... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 L-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 M... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Piracetam Injection, 200mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEw... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs,... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Lab... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 M... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 TNPDR Injection Buffered, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen R... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial, Rx only, Downi... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Co-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial, Rx only, Downing Labs, LLC 400... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Green Tea (EGCG) Injectable, 10mg/mL,10mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 400... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Thiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Sui... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Ph... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 Mc... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Thiotic Acid Injection, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 M... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwe... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Methylcobalamin Buffered Injectable, 5mg/mL, 30mL vial, Rx only, Downing Labs... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 TNPRDC Injection, 6 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Riboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial, Rx only, Downing Labs, ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL vial, Rx only, D... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McE... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial, Rx only, ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Su... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 40... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing La... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Glucosamine HCL Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Magnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 ... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500... Lack of Assurance of Sterility Class II Downing Labs, LLC
Oct 16, 2015 L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001... Lack of Assurance of Sterility Class II Downing Labs, 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.