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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.