Browse Drug Recalls

14,396 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,396 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 14,396 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Nov 10, 2015 Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL,... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounde... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, R... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148,... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx On... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 9, 2015 Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 o... Presence of Foreign Substance Class II Freedom Pharmaceuticals Inc
Nov 4, 2015 Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx... Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes fo... Class II Pine Pharmaceuticals, LLC
Nov 4, 2015 Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -... Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes fo... Class II Pine Pharmaceuticals, LLC
Nov 4, 2015 Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal inje... Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes fo... Class II Pine Pharmaceuticals, LLC
Nov 4, 2015 Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe f... Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes fo... Class II Pine Pharmaceuticals, LLC
Oct 29, 2015 HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton,... Presence of Particulate Matter Class II Amerisource Health Services
Oct 27, 2015 Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topic... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Oct 27, 2015 GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx ... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Oct 27, 2015 Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) ,... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Oct 27, 2015 Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-3... Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new dr... Class II Geritrex Corp
Oct 27, 2015 Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ... Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of... Class II Steris Corp
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 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 Podophyllum 40% Topical, Rx, Western Drug Inc. 106 E. Main Street, Springervi... 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 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 Hydroxocobalamin 1mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Spr... 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 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 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 Calcium Chloride Dihydrate Injection, Rx, Western Drug Inc. 106 E. Main Stree... 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 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 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 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 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 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 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 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 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 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 Salicylic Acid Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, ... 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 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 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 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 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 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 Tev-Tropin (Somatropin) Injection, Rx, Western Drug Inc. 106 E. Main Street, ... 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 Tri-Mix ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville... 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.