Valsartan Tablets — Class II drug recall D-1130-2018
Terminated recall by AVKARE Inc., reported 2018-09-05, distributed nationwide. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-1130-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2018-08-14 |
| Classified | 2018-08-28 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2020-05-07 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 50268-0783-15 |
| Lot numbers | 18491, 19531, 20168, 20671, 21049, 21635 |
| Expiration dates | 2018-10, 2019-04, 2019-05, 2019-08, 2019-10 |
Product
Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
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-1130-2018. 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.