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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 Phenylephrine 500mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, ... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Sodium Hydroxide 10% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerv... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Dexpanthanol B5 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 17-Hydroxyprogesterone 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main ... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Quad Mix Strong Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville,... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Lidocaine Injection 1% , 2%, Rx, Western Drug Inc. 106 E. Main Street, Spring... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Sodium Bicarbonate 8.4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Spring... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Ascorbic Acid 500 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, ... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Squaric Acid 4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville,... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Heparin 1000 Unit/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Spr... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Ace-Promazine 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 Tri-Mix ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Alcohol4%/Bupivicaine0.5% sol, Rx, Western Drug Inc. 106 E. Main Street, Spr... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Tev-Tropin (Somatropin) Injection, Rx, Western Drug Inc. 106 E. Main Street, ... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Super B Complex w/Cyano Inj, Rx, Western Drug Inc. 106 E. Main Street, Spring... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Sodium Chloride 0.9% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerv... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Mupiro/Doxycyc Sinus Rinse, Rx, Western Drug Inc. 106 E. Main Street, Springe... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Glutathione 200 mg/mL SVN Injection, Rx, Western Drug Inc. 106 E. Main Street... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 PZI 40 Insulin (Human) Inj, Rx, Western Drug Inc. 106 E. Main Street, Springe... Lack of Assurance of Sterility Class II Western Drug
Oct 19, 2015 Toradol 60mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springer... Lack of Assurance of Sterility Class II Western Drug
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

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.