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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

6,274 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,274 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 6,274 FDA drug recalls.

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DateProductReasonClassFirm
Jan 15, 2016 methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compou... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx i... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL u... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL, 5 mL unit size, ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abb... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 30 mg/0.25 mg/10 mcg/mL; 10 mL unit si... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 35/1.2 mg/20 mcg/mL; 10 mL unit size, ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 30/1.5 mg/40 mcg/mL; 5 mL unit size, ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharm... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 12/1 mg/9 mcg/mL; 5 mL and 10 mL unit... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine, 35 mg/2.5 mg/mL; 5 mL unit size; refrigerate,This... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This R... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Ab... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL; 5 mL and 10 mL un... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 30/1 mg/20 mcg/mL; 5 mL unit size, re... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 mcg/mL; 5 mL and 10 m... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, This Rx i... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's C... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 5, 2016 Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and... Lack of Assurance of Sterility: Failed preservative effectiveness test Class II Mayne Pharma Usa
Dec 29, 2015 Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous adm... Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture. Class I Complete Pharmacy and Medical Solutions LLC
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

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.