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.

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DateProductReasonClassFirm
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.