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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.

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DateProductReasonClassFirm
Dec 2, 2015 Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, pac... Failed Dissolution Specification Class III Pfizer Inc.
Nov 29, 2015 Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, In... cGMP Deviations; trailer may not have met GMP requirements prior to filling Class II AGA Gas Inc
Nov 25, 2015 MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Onl... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class III Golden State Medical Supply Inc.
Nov 25, 2015 MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 6... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class III Golden State Medical Supply Inc.
Nov 23, 2015 SUPER HERBS 350 mg, 30 capsules per bottle. Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine ... Class I Super Herbs
Nov 19, 2015 NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industri... Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles. Class III Teva Pharmaceuticals USA
Nov 12, 2015 tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ... Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found ... Class II Mariposa Labs LLC
Nov 12, 2015 DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFAT... Failed Impurities/Degradation Specifications: High out of specification test result for impuritie... Class II Teva Pharmaceuticals USA
Nov 11, 2015 Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Ind... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-... Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are bei... Class II Fagron, Inc
Nov 11, 2015 Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, ... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutiona... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspe... Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are bei... Class II Fagron, Inc
Nov 11, 2015 Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Ba... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle spe... Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are bei... Class II Fagron, Inc
Nov 11, 2015 Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, R... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Instituti... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
Nov 11, 2015 Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma In... Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due... Class II RemedyRepack Inc.
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
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuti... Labeling: Not elsewhere classified. NDC number is incorrect on the container. Class III Northwind Pharmaceuticals LLC
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 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 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 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 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 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 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

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.