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Browse Drug Recalls

6,256 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,256 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 6,256 FDA drug recalls.

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DateProductReasonClassFirm
Oct 19, 2015 Vitamin B12 (Cyan) Inj 100mcg/mL, 1000mcg/mL, Rx Western Drug Inc. 106 E. Mai... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Verapamil 120mg/12mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Spr... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Tacrolimus 0.02% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springer... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Super B Comp w/Cyano 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Spring... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 N.A.C. 20% SVN Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, ... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Calcium Gluconate 10% Injection, Rx, Western Drug Inc. 106 E. Main Street, Sp... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Serum Tears 20% Opth, Rx, Western Drug Inc. 106 E. Main Street, Springerville... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Boric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E. Main Street, Springervil... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Wilson's Nasal Irrigation Solution, Rx, Western Drug Inc. 106 E. Main Street,... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Hydrochloric Acid 2mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Sp... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Bladder Mixture Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Super B Complex 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springervil... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Omnitrope 17.4U/10mL Inj-Kit, Rx, Western Drug Inc. 106 E. Main Street, Sprin... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 HCG 1000unit/10mL MTU vial, Rx, Western Drug Inc. 106 E. Main Street, Springe... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Methylcobalamin Injection 1000 mcg/mL, 10000 mcg/mL, Rx, Western Drug Inc. 10... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Novarel "HCG" 10000U/Vial, Rx, Western Drug Inc. 106 E. Main Street, Springer... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Methylcobalamin Injection 10 mg/mL, 20 mg/mL, 30 mg/mL, Rx, Western Drug Inc.... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Lipodissolve 100/50mg Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Spri... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Heparin Sodium 30,000U/30ML Injection, Rx, Western Drug Inc. 106 E. Main Stre... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 VitB12/VitC/VitB3/VitB9 Inj, Rx, Western Drug Inc. 106 E. Main Street, Spring... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Quad Mix Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizon... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Butor/Nal/Hydro Nasal Susp, Rx, Western Drug Inc. 106 E. Main Street, Springe... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Tri-Amino OAC 1:1:1 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Sprin... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Cyancobalamin 2000mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Ketorolac 40mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Spring... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Gent 80 mg/Liter Nasal, Rx, Western Drug Inc. 106 E. Main Street, Springervil... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Procaine HCl Injection 1%, 2%, Rx, Western Drug Inc. 106 E. Main Street, Spri... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Testost CYP 200mg/mL SUS, Rx, Western Drug Inc. 106 E. Main Street, Springerv... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Potassium Chloride 40 mEq/mL Inj, Rx, Western Drug Inc. 106 E. Main Street, S... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Testosterone CYP Inj 200 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Spr... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 T.C.A 30% Acid Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, ... Lack of Assurance of Sterility Class II Western Drug
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
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 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 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 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 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 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 Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial, Rx only, ... 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 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 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 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 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 Methylcobalamin Buffered Injectable, 5mg/mL, 30mL vial, Rx only, Downing Labs... 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 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 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 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-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 Mc... 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.