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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
Mar 10, 2015 BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 ESTRIOL (E3) W/V (weight/volume) VERSABASE 3MG/ML Transdermal cream, dispens... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PR... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) VAN ... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding... Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin. Class II Freedom Pharmaceuticals Inc
Mar 9, 2015 Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, R... Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impac... Class II Navinta LLC
Mar 6, 2015 MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx onl... Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect ... Class I Hospira Inc.
Mar 6, 2015 DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) Fuse... Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia... Class II Fusion Pharmaceuticals, LLC
Mar 5, 2015 0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospi... Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution. Class I Hospira Inc.
Mar 5, 2015 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), U... Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative p... Class II Hospira Inc.
Mar 2, 2015 Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx ... Defective Container: Confirmed customer complaints of leaking bottles. Class II Safecor Health, LLC
Mar 2, 2015 Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx O... Failed dissolution specifications Class II American Health Packaging
Feb 27, 2015 Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bo... Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride. Class II Akorn, Inc.
Feb 27, 2015 Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Ma... Subpotent Drug Class III AVKARE Inc.
Feb 27, 2015 Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Man... Subpotent Drug Class III AVKARE Inc.
Feb 26, 2015 Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufac... Failed Impurities/Degradation Specifications Class III Pfizer Inc.
Feb 26, 2015 Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manuf... Failed Impurities/Degradation Specifications Class III Pfizer Inc.
Feb 25, 2015 Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by:... Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with qu... Class II Heritage Pharmaceuticals, Inc.
Feb 25, 2015 RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcu... Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with qu... Class II Heritage Pharmaceuticals, Inc.
Feb 25, 2015 Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, M... Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. Class II Noven Pharmaceuticals, Inc.
Feb 24, 2015 Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syring... Presence of particulate. Class II SCA Pharmaceuticals
Feb 23, 2015 Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only,... Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic an... Class II Sagent Pharmaceuticals Inc
Feb 23, 2015 Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5... Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic an... Class II Sagent Pharmaceuticals Inc
Feb 23, 2015 PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan H... Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product. Class II Qualitest Pharmaceuticals
Feb 18, 2015 Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL... Lack of Assurance of Sterility; due to leaking vials Class II Mylan Institutional LLC
Feb 18, 2015 Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL ... Lack of Assurance of Sterility; due to leaking vials Class II Mylan Institutional LLC
Feb 18, 2015 KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside... Crystallization Class II RemedyRepack Inc.
Feb 16, 2015 Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5... Failed Impurities/Degradation Specifications; 12 month stability testing. Class III West-Ward Pharmaceutical Corporation
Feb 13, 2015 AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32... Failed tablet specifications: One lot was found to contain oversized tablets. Class II Qualitest Pharmaceuticals
Feb 12, 2015 Glycerin 98.5% Opth. Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Sout... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Methylcobalamin 1000 mcg/mL Injection, Health Innov Pharmacy, 295 Pinehurst A... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Phen 15 mg - Topri 92 mg SR Cap (Qsymia), Health Innov Pharmacy, 295 Pinehurs... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Colchicine 0.6 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pi... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Naltrexone 4.5 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pi... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 DHEA 10 mg SR Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines,... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Trimix #1 (Original) Injection (papaverine 75 mg - phentolamine 2.5 mg - PGE ... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Pregnenolone 20 mg SR Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Sout... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Progest 200 mg/1 mL Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Sodium Tetradecyl 1% Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Sou... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Ibuprofen 10% cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Nadolol 10 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern P... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Diclo 3% - Bacl 2% - Cyclo 2% - Lidoc 2% Cream, Health Innov Pharmacy, 295 Pi... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Nortriptyline 10 mg/5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Sout... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Phenylephrine 0.5% Solution (Bottle), Health Innov Pharmacy, 295 Pinehurst Av... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Verapamil HCl 15% Topical Cream, Health Innov Pharmacy, 295 Pinehurst Ave, So... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Fortifed Tobramycin 15 mg/1 mL Opth., Health Innov Pharmacy, 295 Pinehurst Av... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Triest 5 mg - Progest 150 mg Capsule, Health Innov Pharmacy, 295 Pinehurst Av... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Pyrimethamine 2 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, South... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Spironolactone 5 mg/mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southe... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc

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.