Valsartan 80 mg tablets — Class II drug recall D-1027-2018
Terminated recall by Bryant Ranch Prepack Inc., reported 2018-08-08, distributed in FL, HI, IN. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-1027-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bryant Ranch Prepack Inc., Burbank, CA, United States |
| Recall initiated | 2018-07-27 |
| Classified | 2018-08-02 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2021-04-22 |
| Distributed | FL, HI, IN |
| Quantity | 690 tablets |
| Reason classes | cgmp, specification failure |
| NDC | 63629-6922-02, 63629-6922-03, 63629-6922-04 |
| Lot numbers | 02/19, 111158 |
Product
Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
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-1027-2018. 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.