Valsartan Tablets — Class II drug recall D-1109-2018
Ongoing recall by A-S Medication Solutions LLC., reported 2018-08-29, distributed nationwide. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-1109-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | A-S Medication Solutions LLC., Libertyville, IL, United States |
| Recall initiated | 2018-07-17 |
| Classified | 2018-08-18 |
| Reported by FDA | 2018-08-29 |
| Distributed | Nationwide (US) |
| Quantity | 178 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 54569-6582-00, 54569-6582-01 |
| Lot numbers | 7208140, 7212260, 7212261, 7221155, 7222161, 7258177, 7276228, 8109170, 8109171 |
Product
Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
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-1109-2018. 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.