Valsartan Tablets — Class II drug recall D-1108-2018
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-1108-2018 |
|---|---|
| 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 | 666 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 54569-6583-00, 54569-6583-01 |
| Lot numbers | 7207135, 7212280, 7215073, 7222162, 7222163, 7227175, 7285177, 8095248, 8095249, 8162190, 8183227 |
Product
Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), 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-1108-2018. 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.