Valsartan and Hydrochlorothiazide Tablets — Class II drug recall D-1111-2018
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-1111-2018 |
|---|---|
| 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 | 531 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 54569-6488-00 |
| Lot numbers | 7132187, 7160161, 7180150, 7268239, 7293219, 7362231, 8074161, 8110184, 8114178, 8115123, 8197215 |
Product
Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0
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-1111-2018. 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.