Valsartan/HCTZ 160 mg/12 — Class II drug recall D-1020-2018
Terminated recall by RemedyRepack Inc., reported 2018-08-08, distributed in FL. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-1020-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2018-07-17 |
| Classified | 2018-07-31 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2018-10-17 |
| Distributed | FL |
| Reason classes | cgmp, specification failure |
| Lot numbers | 07/18, B0318652-070617 |
Product
Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
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-1020-2018. 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.