Browse Drug Recalls

3,430 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,430 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 3,430 FDA drug recalls.

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DateProductReasonClassFirm
Aug 3, 2018 QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chlo... 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 Spray (sodium chloride), 0.65%, packaged as ... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL O... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relie... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Rexall, Extra Moisturizing No Drip 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 Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (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, Nasal Moisturizing Spray, Contains: Sodium Ch... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl O... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01... 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 Gel with Soothing Aloe, packaged as a) Baby Net Wt. ... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 F... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer La... 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, Nasal Spray (oxymetazoline HCl 0.05%), Reg... 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 Deco... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Walgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum ... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65%, pa... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Thayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (... 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, No Drip Nasal Spray (oxymetazoline HCl) Na... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, ... 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 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

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.