Valsartan and Hydrochlorothiazide — Class II drug recall D-0985-2018
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-0985-2018 |
|---|---|
| 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 | 164,922 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 00591-2318-19 |
| Lot numbers | 1191188M, 1191189M, 1191190M, 1199220M, 1217576M, 1217577M, 1217578M, 1220832M, 1220833M, 1247283M, 1247284M, 1247285M, 1247286M, 1247287A, 1280632M, 1280633M |
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.
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-0985-2018. 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.