Valsartan Tablets USP 320 mg — Class II drug recall D-1107-2018
Terminated recall by Preferred Pharmaceuticals, Inc, reported 2018-08-29, distributed in AL. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-1107-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preferred Pharmaceuticals, Inc, Anaheim, CA, United States |
| Recall initiated | 2018-08-15 |
| Classified | 2018-08-17 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2019-01-18 |
| Distributed | AL |
| Reason classes | cgmp, specification failure |
| NDC | 68788-6882-09 |
| Lot numbers | G2017F |
Product
Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9
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-1107-2018. 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.