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 |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Dec 31, 2014 | Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Ad... | Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 3... | Class II | Valeant Pharmaceuticals North America LLC |
| Dec 9, 2014 | Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size:... | Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 ... | Class III | Akorn, Inc. |
| Dec 3, 2014 | MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake F... | Failed Stability Specifications: Product is subpotent and has out of specification known and unkn... | Class I | Hospira Inc. |
| Nov 14, 2014 | Amoxicillin Trihydrate active pharmaceutical ingredient packaged in varying g... | Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed betwe... | Class II | Attix Pharmaceuticals |
| Nov 14, 2014 | Procaine Penicillin G active pharmaceutical ingredient packaged in varying gr... | Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed betwe... | Class II | Attix Pharmaceuticals |
| Nov 14, 2014 | Ticarcillin Sodium/Potassium Clavulanate (30:1) active pharmaceutical ingredi... | Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed betwe... | Class II | Attix Pharmaceuticals |
| Nov 14, 2014 | Piperacillin Sodium active pharmaceutical ingredient packaged in varying gram... | Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed betwe... | Class II | Attix Pharmaceuticals |
| Oct 22, 2014 | Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) ... | Failed Dissolution Specifications: Product found to be out of specification (OOS) during stabilit... | Class II | Prometheus Laboratories Inc. |
| Oct 16, 2014 | Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, R... | Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified im... | Class II | Pharmaceutical Associates Inc |
| Oct 10, 2014 | MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and D... | Subpotent; 6 month stability time point | Class III | American Health Packaging |
| Oct 9, 2014 | GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 50... | Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification res... | Class II | Micro Labs Usa, Inc ... |
| Oct 2, 2014 | Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, M... | Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 ... | Class III | Valeant Pharmaceuticals International |
| Oct 2, 2014 | VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-co... | Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point. | Class II | West-Ward Pharmaceutical Corp. |
| Oct 2, 2014 | candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactur... | Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated ... | Class III | Sandoz, Inc |
| Oct 2, 2014 | Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufacture... | Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 ... | Class III | Valeant Pharmaceuticals International |
| Sep 26, 2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles... | Failed Dissolution Specifications; 12 month stability time point | Class II | Sun Pharma Global Inc. |
| Sep 26, 2014 | Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/cart... | Failed Dissolution Specification; at the 6-month stability time point | Class II | Forest Pharmaceuticals Inc |
| Sep 18, 2014 | E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -c... | Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months. | Class III | Bracco Diagnostic Inc |
| Sep 15, 2014 | Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured ... | Failed Dissolution Specifications: The product did not meet the acceptance criteria for the disso... | Class II | Astellas Pharma US 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.