Valsartan 160 mg Tablets — Class II drug recall D-1101-2018
Terminated recall by RemedyRepack Inc., reported 2018-08-22, distributed in FL, VA. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-1101-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2018-08-10 |
| Classified | 2018-08-16 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2018-10-12 |
| Distributed | FL, VA |
| Reason classes | cgmp, specification failure |
| NDC | 61786-0792-19 |
| Lot numbers | B0335344-081717, B0363364-110917, B0384871-010318, B0391225-012218, B0408458-030618, B0436862-051518 |
| Expiration dates | 2018-08, 2018-11, 2019-01, 2019-03, 2019-05 |
Product
Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
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-1101-2018. 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.