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Browse Drug Recalls

91 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 91 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 91 FDA drug recalls.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 Cyancobalamin 2000mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,... 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 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 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 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 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 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 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 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 1000 mcg/mL, 10000 mcg/mL, Rx, Western Drug Inc. 10... 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 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 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 Bladder Mixture Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville... 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 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 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 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 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 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 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 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 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 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 B-12 1000/B6 1000 mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 M-Cobalamin 2/Folate 5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Stre... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Magnesium Chloride Injection, Rx, Western Drug Inc. 106 E. Main Street, Sprin... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Medroxyprogesterone 150/LID 5 mg/mL Injection, Rx, Western Drug Inc. 106 E. M... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 ... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 M-Cobalamin (B12) Injection 200 mcg, 2000mcg, Rx, Western Drug Inc. 106 E. M... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Folic Acid Injection 5 mg/mL,10 mg/mL, Rx, Western Drug Inc. 106 E. Main Stre... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 AMP50/B121MG Complex Mix/ML Injection, Rx, Western Drug Inc. 106 E. Main Stre... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Calcium EDTA 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Sp... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Cyclosporine 1% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerv... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Cantharidin 0.7% Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Vitamin B-Complex 100 Injection, Rx, Western Drug Inc. 106 E. Main Street, Sp... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Magnesium Sulfate 50% Injection, Rx, Western Drug Inc. 106 E. Main Street, Sp... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Triamcin40/Lido5 mg/mL Sus, Rx, Western Drug Inc. 106 E. Main Street, Springe... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Test Cyp/Test Prop 1:1 Injection 100mg/mL, 120mg/mL, 150mg/mL, 160mg/mL, 170m... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Depo-Testadiol 10/5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Hydroxocobalamin 1mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, ... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 HCG 10,000U/10mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springe... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Jessners Dermal Solution, Rx, Western Drug Inc. 106 E. Main Street, Springerv... Lack of Assurance of Sterility Class II Western Drug

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.