Valsartan — Class II drug recall D-1098-2018
Terminated recall by Northwind Pharmaceuticals LLC, reported 2018-08-22, distributed in IN. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-1098-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Northwind Pharmaceuticals LLC, Indianapolis, IN, United States |
| Recall initiated | 2018-07-18 |
| Classified | 2018-08-15 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2023-03-25 |
| Distributed | IN |
| Quantity | 14 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 51655-0654-52 |
| Lot numbers | UT48100001 |
| Expiration dates | 2019-09-30 |
Product
Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52
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-1098-2018. 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.