Valsartan and Hydrochlorothiazide — Class II drug recall D-0983-2018
Ongoing recall by Teva Pharmaceuticals USA, reported 2018-08-01, distributed nationwide. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-0983-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2018-07-16 |
| Classified | 2018-07-24 |
| Reported by FDA | 2018-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 99,554 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 00591-2317-19 |
| Lot numbers | 1191164M, 1191165M, 1191166M, 1191167A, 1225612M, 1250717M, 1256111M, 1288798M |
Product
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 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 0591-2317-19.
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0983-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.