Browse Drug Recalls
1,056 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,056 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 1,056 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 18, 2015 | Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for... | Failed Dissolution Specifications: During routine stability testing at the 12 month time point, ... | Class III | Qualitest Pharmaceuticals |
| 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 | 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 | 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 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 13, 2015 | Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx On... | Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548). | Class III | West-Ward Pharmaceutical Corp. |
| May 11, 2015 | Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manuf... | Failed Dissolution Specifications: OOS result during stability testing | Class II | Teva Pharmaceuticals USA |
| May 7, 2015 | QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For... | Failed Impurities/Degradation Specifications: out of specification test results for an impurity d... | Class III | Teva Pharmaceuticals USA |
| Apr 24, 2015 | Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. R... | Failed Stability Specifications: Product failed to meet 12 months long term stability specificati... | Class II | Romark Laboratories, L.C. |
| Apr 15, 2015 | Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 bli... | Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported f... | Class III | Sandoz, Inc |
| Apr 2, 2015 | Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 co... | Subpotent Drug: The firm received an out of specification result for Assay (potency was below spe... | Class II | Boehringer Ingelheim Roxane Inc |
| 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 |
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.