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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Sp... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spr... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 22, 2015 | Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, ... | Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo... | Class II | Grato Holdings, Inc. |
| Dec 21, 2015 | Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bo... | Failed Dissolution Specifications: low test results at the 18 month time-point | Class II | Teva North America |
| Dec 21, 2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Dec 21, 2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Dec 21, 2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Dec 3, 2015 | Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 2... | Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the la... | Class II | GlaxoSmithKline, LLC |
| 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 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 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 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 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 | 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 | 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 | 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, 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 | 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 | 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 | 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 | 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 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 |
| 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 |
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.