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 17, 2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by:... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 m... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 m... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 15, 2018 | Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx On... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Preferred Pharmaceuticals, Inc |
| Aug 14, 2018 | Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 14, 2018 | Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-7... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 14, 2018 | Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-78... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 14, 2018 | Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-78... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 10, 2018 | Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, Rem... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Aug 10, 2018 | Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, Rem... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Aug 10, 2018 | Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, Reme... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx O... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Onl... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx On... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 3, 2018 | Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slipper... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube,... | 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 Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochlo... | 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 | Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distribu... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed... | 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) Saline Nasal Moisturi... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| 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 |
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.