Browse Drug Recalls
3,458 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,458 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 3,458 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 3, 2018 | Best Choice, 12 Hour Sinus Relief, Nasal Spray (Oxymetazoline Hydrochloride 0... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Walgreens, NO DRIP Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decon... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, D... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tub... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Best Choice, 12 Hour No-Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) ... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazolin... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Best Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benza... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bot... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Premier Value, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodi... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Rite Aid Pharmacy, nasal relief NO DRIP PUMP SPRAY nasal spray, (oxymetazolin... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Jul 30, 2018 | Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Ph... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | NuCare Pharmaceuticals Inc |
| Jul 30, 2018 | Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | NuCare Pharmaceuticals Inc |
| Jul 30, 2018 | Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Ph... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | NuCare Pharmaceuticals Inc |
| Jul 27, 2018 | Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottle... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Bryant Ranch Prepack Inc. |
| Jul 27, 2018 | Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Pack... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Bryant Ranch Prepack Inc. |
| Jul 27, 2018 | Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bott... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Bryant Ranch Prepack Inc. |
| Jul 24, 2018 | 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium S... | CGMP deviations: Product was released while a hood certification discrepancy was being investigated. | Class II | PharMEDium Services, LLC |
| Jul 24, 2018 | 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in... | CGMP deviations: Product was released while a hood certification discrepancy was being investigated. | Class II | PharMEDium Services, LLC |
| Jul 24, 2018 | 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL... | CGMP deviations: Product was released while a hood certification discrepancy was being investigated. | Class II | PharMEDium Services, LLC |
| Jul 18, 2018 | Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Phar... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | MAJOR PHARMACEUTICALS |
| Jul 18, 2018 | AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bot... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Avkare Incorporated |
| Jul 18, 2018 | Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: No... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Northwind Pharmaceuticals LLC |
| Jul 18, 2018 | AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottl... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Avkare Incorporated |
| Jul 18, 2018 | Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Ph... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Northwind Pharmaceuticals LLC |
| Jul 18, 2018 | AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bot... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Avkare Incorporated |
| Jul 18, 2018 | Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pha... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Northwind Pharmaceuticals LLC |
| Jul 18, 2018 | AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bott... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Avkare Incorporated |
| Jul 18, 2018 | Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind P... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Northwind Pharmaceuticals LLC |
| Jul 18, 2018 | AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Avkare Incorporated |
| Jul 18, 2018 | Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pha... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | MAJOR PHARMACEUTICALS |
| Jul 17, 2018 | Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Jul 17, 2018 | Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochloroth... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | A-S Medication Solutions LLC. |
| Jul 17, 2018 | Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | A-S Medication Solutions LLC. |
| Jul 17, 2018 | Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochloroth... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | A-S Medication Solutions LLC. |
| Jul 17, 2018 | Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottl... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | A-S Medication Solutions LLC. |
| Jul 17, 2018 | Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Jul 17, 2018 | Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (... | CGMP Deviations | Class II | Longbow First Aid Products Manufactory |
| Jul 17, 2018 | Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (ND... | CGMP Deviations | Class II | Longbow First Aid Products Manufactory |
| Jul 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, U... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bo... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, U... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Teva Pharmaceuticals USA |
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tabl... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical 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.