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 |
|---|---|---|---|---|
| Dec 31, 2018 | Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Aurobindo Pharma USA Inc. |
| Dec 20, 2018 | LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Torrent Pharma Inc. |
| Dec 20, 2018 | LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Torrent Pharma Inc. |
| Dec 20, 2018 | LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Torrent Pharma Inc. |
| Dec 20, 2018 | LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Torrent Pharma Inc. |
| Dec 20, 2018 | LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... | Class II | Torrent Pharma Inc. |
| Dec 19, 2018 | Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, ... | CGMP Deviations | Class II | Roberts Home Medical LLC |
| Dec 18, 2018 | CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP ... | CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | Class II | LGM Pharma LLC |
| Nov 27, 2018 | Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, ... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 27, 2018 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, ... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Teva Pharmaceuticals USA |
| Nov 20, 2018 | Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only,... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manuf... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count b... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 16, 2018 | SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per fil... | cGMP violations noted during the firm's most recent inspection. | Class II | CAO Group, Inc. |
| Nov 16, 2018 | fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3c... | cGMP violations noted during the firm's most recent inspection. | Class II | CAO Group, Inc. |
| Nov 16, 2018 | FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, ... | cGMP violations noted during the firm's most recent inspection. | Class II | CAO Group, Inc. |
| Nov 16, 2018 | BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%... | cGMP violations noted during the firm's most recent inspection. | Class II | CAO Group, Inc. |
| Nov 2, 2018 | IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... | Class II | Golden State Medical Supply Inc. |
| Nov 2, 2018 | IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... | Class II | Golden State Medical Supply Inc. |
| Nov 2, 2018 | IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciG... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... | Class II | Golden State Medical Supply Inc. |
| Nov 1, 2018 | Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Sandoz, Inc |
| Oct 29, 2018 | Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-11... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Sciegen Pharmaceuticals Inc |
| Oct 29, 2018 | GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30),... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Sciegen Pharmaceuticals Inc |
| Oct 29, 2018 | Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Sciegen Pharmaceuticals Inc |
| Oct 29, 2018 | GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured b... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Sciegen Pharmaceuticals Inc |
| Oct 29, 2018 | Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Ph... | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... | Class II | Westminster Pharmaceuticals Llc |
| Oct 29, 2018 | GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), ... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Sciegen Pharmaceuticals Inc |
| Oct 29, 2018 | Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen P... | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... | Class II | Westminster Pharmaceuticals Llc |
| Oct 29, 2018 | Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... | Class II | Sciegen Pharmaceuticals Inc |
| Oct 29, 2018 | Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen P... | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... | Class II | Westminster Pharmaceuticals Llc |
| Oct 26, 2018 | Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8... | CGMP Deviations: Product was released to market prior to microbiological testing. | Class II | S.C. Johnson Professional |
| Oct 26, 2018 | deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl.... | CGMP Deviations: Product was released to market prior to microbiological testing. | Class II | S.C. Johnson Professional |
| Oct 24, 2018 | Irbesartan Bulk Active Pharmaceutical Ingredient. | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... | Class II | Aurobindo Pharma Limited (Unit I) |
| Oct 11, 2018 | HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP... | CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for... | Class II | Lannett Company, Inc. |
| Oct 9, 2018 | AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spra... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spr... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
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.