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Browse Drug Recalls

1,733 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,733 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 1,733 FDA drug recalls in 2015.

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DateProductReasonClassFirm
Oct 19, 2015 Salicylic Acid Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, ... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Tri-Test 1:1:1 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, ... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Sal-Acid 60% Plaster Paste, Rx, Western Drug Inc. 106 E. Main Street, Springe... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Tacrolimus 0.03% Opth Oint, Rx, Western Drug Inc. 106 E. Main Street, Springe... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Testosterone Injection 100mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 10... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Furosemide 20 mg/mL svn Sol, Rx, Western Drug Inc. 106 E. Main Street, Spring... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Triamcin 40mg/mL Susp, Rx, Western Drug Inc. 106 E. Main Street, Springervill... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Benadryl 50mg/2mL Pres-Free Injection, Rx, Western Drug Inc. 106 E. Main Stre... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Dep-Estradiol 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, S... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Glutathione 300 mg/1.5 mL Injection, Rx, Western Drug Inc. 106 E. Main Street... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Progesterone Cyp Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Calcium Chloride Dihydrate Injection, Rx, Western Drug Inc. 106 E. Main Stree... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Tri-Mix LOW ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerv... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Marcaine 0.24%/Ethanol 4% Injection, Rx, Western Drug Inc. 106 E. Main Street... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Sermorelin Injection 10mg/10mL,10mg/mL, 20mg/10mL, 9mg/9mL, Rx, Western Drug ... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Hydroxocobalamin 1mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Spr... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Dextrose 50% Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Pyridoxine B6 100mg Inj, Rx, Western Drug Inc. 106 E. Main Street, Springervi... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Podophyllum 40% Topical, Rx, Western Drug Inc. 106 E. Main Street, Springervi... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Cantharitus Multi-Mix Prep, Rx, Western Drug Inc. 106 E. Main Street, Springe... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Stree... Lack of Assurance of Sterility Class II Western Drug
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

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.