Vehicle Safety Product Safety Food Safety Pet Safety Drug Safety Device Safety Workplace Safety Bridge Safety Aviation Safety Dam Safety Nursing Homes Water Safety Railroad Safety Pipeline Safety Environmental

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.

Clear
DateProductReasonClassFirm
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 HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL ... Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... Class III Oasis Medical, Inc.
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 HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe,... Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... Class III Oasis Medical, Inc.
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
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

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.