Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity
Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the detection of a carcinogen impurity in a pharmaceutical product represents a significant health risk, meeting the criteria for a Severe rating.
Plain-English summary
Teva Pharmaceuticals USA is recalling 164,922 bottles of Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg, 90-count. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of a carcinogen impurity in the active pharmaceutical ingredient (API) used to manufacture the drug product.
The affected product is distributed throughout the United States, including Hawaii and Puerto Rico. The recall includes specific lot numbers: 1191188M, 1191189M, 1191190M, 1199220M, 1217576M, 1217577M, 1217578M, 1220832M, 1220833M, 1247283M, 1247284M, 1247285M, 1247286M, 1247287A, 1280632M, and 1280633M. The product was manufactured by Arrow Pharma (Malta) Ltd. in India and distributed by Actavis Pharma, Inc. in Parsippany, NJ.
Consumers and healthcare providers should check their medication bottles for the NDC 0591-2318-19 and the listed lot numbers. If the product matches the recalled description, it should be returned to the pharmacy or healthcare provider for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Antihypertensive
- Hazard
- Affected units
- 164,922
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Lot Numbers: 1191188M
- 1191189M
- 1191190M
- 1199220M
- 1217576M
- 1217577M
- 1217578M
- 1220832M
- 1220833M
- 1247283M
- 1247284M
- 1247285M
- 1247286M
- 1247287A
- 1280632M
- 1280633M
Distribution
Part of a larger recall action
This product is one of 9 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Teva Pharmaceuticals USA
See all →- ModerateDoxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09
- LowPrescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
- ModerateTretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
- LowMimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
FDA (Drugs) · 2022-02-09
- ModerateBrinzolamide Ophthalmic Suspension recalled for defective container caps
FDA (Drugs) · 2022-01-26
Same hazard · carcinogen impurity
See all →- SevereMacleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Carcinogen
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Irbesartan Bulk Ingredient Due to Carcinogen Impurity
FDA (Drugs) · 2018-11-07
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12