Browse Drug Recalls

1,045 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,045 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 1,045 FDA drug recalls.

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DateProductReasonClassFirm
Mar 26, 2015 Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihista... Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Mar 25, 2015 PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10... Failed Impurities/Degradation Specifications: A stability lot was out of specification for a know... Class III Qualitest Pharmaceuticals
Mar 10, 2015 Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by... Failed Impurities/Degradation Specifications: during long-term stability testing. Class II Mutual Pharmaceutical Company, Inc.
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 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 12, 2015 EDTA 3% Eye Drops, 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 Laureth-P 1% Injection (Polidocanol), 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 Hydroxyurea 100 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 Dexamethasone 4 mg/mL Iontophoresis, Health Innov Pharmacy, 295 Pinehurst Ave... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Nexium 2 mg/1 mL Solution, 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 Folic Acid 2 mg/1 mL Susp, 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 Voriconazole 1% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Souther... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Thymol 2% Solution, 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 Coconut Oil Suppository, 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 Fortified Vancomycin 25 mg/1 mL Opth Drops, Health Innov Pharmacy, 295 Pinehu... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Levodopa 250 mg NSR Capsules,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
Feb 12, 2015 HCG 1000 Units/mL Injection, 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
Feb 12, 2015 Testosterone 100 mg/1 mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave,... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Nystatin 50,000 Units Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, ... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Boric Acid Vaginal Capsules, 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
Feb 12, 2015 Carvedilol 1.25 mg/mL, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pin... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pin... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Rifampin 25 mg/1 mL Susp, 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 Warfarin 2.5 ng Lactose Free Caps, Health Innov Pharmacy, 295 Pinehurst Ave, ... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Lansoprazole 3 mg/mL Susp, 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 Pyridoxine 100 mg/1 mL Syrup, 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 Nitroglycerin 0.2% Compd Cream, 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 Promethazine 25 mg/0.5 mLGel, 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 Nifedipine 0.2% - Lidocaine 2% Jelly, 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 Leucovorin 1 mg/1 mL Susp, 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 Ciprodex with Amphoteracin B (ear drops), 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 Methenamine/Phenyl Salicylate Capsule, 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 Glycopyrrolate 0.2 mg/1 mL Susp (Robinul), Health Innov Pharmacy, 295 Pinehur... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Hydroquinone 10% Cream, 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 Cyclandelate 200 mg Caps, 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 Acetylcysteine 10% Opth Solution, Health Innov Pharmacy, 295 Pinehurst Ave, S... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Serum 50% BSS 50% Opth Drops, 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 Estradiol 0.01% Vaginal Cream, 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 Estriol 5% Cream Vaginal Cream, 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 Sildenafil 10 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Souther... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Azithromycin 100 mg Rectal Suppository, Health Innov Pharmacy, 295 Pinehurst ... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Cyanocobalamin 2000mcg/1ml Injection, 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 Renacidin Irrigation 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 BLT New Formula 20%/7%/7% Sample, Health Innov Pharmacy, 295 Pinehurst Ave, S... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 T4 66mcg - T3 10mcg SR Capsule, 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 Baclofen 20 mg/4 mL Susp., 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 Hydrocortisone 1.6 mg/0.5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, ... Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection obse... Class II Health Innovations Pharmacy, Inc
Feb 12, 2015 Keto 10%-Gabap 10%-Ketamine 2% Cream, 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 DNCB 0.3% Ointment, 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 Phospholine Iodide 0.03% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave... 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.