Valsartan/HCTZ 160/12 — Class II drug recall D-1037-2018
Terminated recall by NuCare Pharmaceuticals Inc, reported 2018-08-15, distributed in CA. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-1037-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NuCare Pharmaceuticals Inc, Orange, CA, United States |
| Recall initiated | 2018-07-30 |
| Classified | 2018-08-03 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2021-04-22 |
| Distributed | CA |
| Reason classes | cgmp, specification failure |
| NDC | 68071-4311-09 |
| Lot numbers | U01779 |
| Expiration dates | 2019-04-30 |
Product
Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9
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-1037-2018. 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.