Valsartan tablets 160 mg — Class II drug recall D-1022-2018
Terminated recall by H J Harkins Company Inc dba Pharma Pac, reported 2018-08-08. Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-1022-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | H J Harkins Company Inc dba Pharma Pac, Grover Beach, CA, United States |
| Recall initiated | 2018-07-26 |
| Classified | 2018-08-01 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2019-01-18 |
| Quantity | 540 tablets |
| Reason classes | specification failure |
| NDC | 43547-0369-09 |
| Lot numbers | 02/19, 343B17015, VSA000OV |
Product
Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.
Reason for recall
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-1022-2018. 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.