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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
May 28, 2015 Cefepime HCl, CEFEPIME 850 mg NS 50mL AccuFlo, Qty: 12 50 mL Bags, Rx Only. ... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 3:1, 1050 mL Bags, Qty: 6, Base Formula Dextrose 70%, Travasol 10%, Intr... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Vancomycin HCl, Vancomycin 1500mg / D5W 265mL, Qty: 2 265 mL Bags, Rx Only. ... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 3:1, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intra... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 VANC 50MCG/ML-HEP 100U/ML in 2ML, Packed in 2 mL Units, Rx Only. Compounded ... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Gentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syrin... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Ceftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags, Rx Only. Compounded by: Unit... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 HYDROmorphone HCl PF, Hydromorphone 1000 mg / NS 500 mL, Qty: 1 500 mL Bag, R... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo, Qty: 4 240 mL Bags, Rx Only.... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Ceftriaxone Sodium, Ceftriaxone 2gm / NS 50mL, Qty: 12 50 mL Bags, Rx Only. ... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Fluorouracil 5760mg / D5W 265mL Qty: 1 265 mL Bag, Rx Only. Compounded by: U... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 CEFEPIME 1gm / NS 50mL AccuFlo, Packaged in 50 mL Bags, Rx Only. Compounded b... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 VANCOMYCIN HCL 250mg / NS 6mL syringe, Packaged in 6 mL Syringes, Rx Only. Co... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Fluorouracil 4600mg / D5W 292 mL, Qty: 1 292 mL Bag, Rx Only. Compounded by:... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 3:1, 1800 ml Bags, Qty: 2, Base Formula NaCl 0.9%, Dextrose 70%, Travasol... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Fluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: U... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 27, 2015 E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil po... Failed stability specifications:This recall has been initiated due to out of specification result... Class III Bracco Diagnostic Inc
May 22, 2015 Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA L... cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wo... Class II Blenheim Pharmacal, Inc.
May 22, 2015 Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL... Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay. Class I Pharmedium Services, LLC
May 22, 2015 Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,... Failed Stability Specification: out of specification result obtained for the Particle Size Distri... Class III Novartis Pharmaceuticals Corp.
May 22, 2015 Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, R... Failed Dissolution Specifications; exceeded specification at the 9 hour time point Class II Dr. Reddy's Laboratories, Inc.
May 22, 2015 Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 25... Failed Dissolution Specifications; exceeded specification at the 9 hour time point Class II Dr. Reddy's Laboratories, Inc.
May 22, 2015 Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,... Failed Stability Specification: out of specification result obtained for the Particle Size Distri... Class III Novartis Pharmaceuticals Corp.
May 22, 2015 Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt... cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wo... Class II Blenheim Pharmacal, Inc.
May 21, 2015 SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: In... Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey ... Class II Medtech Products, Inc.
May 21, 2015 CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 9... Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial... Class II Takeda Pharmaceuticals North America, Inc.
May 20, 2015 Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only,... Failed Dissolution Specifications: Low out of specification dissolution results. Class II Mylan Lab Inc
May 19, 2015 Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV... Failed pH Specifications: 12 month stability testing Class III Hospira Inc.
May 18, 2015 HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Adv... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Co... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE,... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Adv... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advan... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compo... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 NANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compounding Ph... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 NANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Advanced C... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanced Compo... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced ... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 SODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJECTABLE, ... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 SODIUM HYALURONATE (STERILE WATER) 2.5 ML VIAL 20MG/ML INJECTABLE, Advanced C... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 VITAMIN D3 (OLIVE OIL) (30ML VIAL) 50,000 UNITS/ML INJECTABLE, Advanced Compo... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 SODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced Compoundi... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTABLE, Adva... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 ESTRADIOL CYPIONATE (SESAME OIL) 10ML, 30ML VIAL 5MG/ML INJECTABLE, Advanced ... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 GLYCERIN (STERILE WATER) 100ML 71% INJECTABLE, Advanced Compounding Pharmacy,... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 15, 2015 Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispense... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial,... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, c... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy
May 15, 2015 Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, comp... Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection Class II Montana Compounding Pharmacy

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.