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Browse Drug Recalls

6,252 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,252 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 6,252 FDA drug recalls.

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DateProductReasonClassFirm
Dec 29, 2015 Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, ... Lack of assurance of sterility Class II TexasStar Pharmacy
Dec 24, 2015 IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syr... Lack of Assurance of Sterility Class II Amerita Specialty Infusion Services
Dec 24, 2015 Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Comp... Lack of Assurance of Sterility Class II Amerita Specialty Infusion Services
Nov 10, 2015 0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 14... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Car... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, Sa... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Com... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Ca... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Piperacillin/Tazobactam (Zosyn) Accuflo bag, a) 18 g/NS 275 mL b) 4.5 g/NS ... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, Sa... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, ... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compou... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compound... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San A... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL, Rx Only, Compo... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San ... Lack of Assurance of Sterility Class II Walgreens Infusion Services
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 10, 2015 Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, ... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option C... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL ... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, C... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Insulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San A... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 1... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Cefepime 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 Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, R... Lack of Assurance of Sterility Class II Walgreens Infusion Services
Nov 10, 2015 Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, S... Lack of Assurance of Sterility Class II Walgreens Infusion Services
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

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.