Unit Dose Valsartan Tablets — Class II drug recall D-0967-2018
Terminated recall by MAJOR PHARMACEUTICALS, reported 2018-08-01, distributed nationwide. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-0967-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Recalling firm | MAJOR PHARMACEUTICALS, Livonia, MI, United States |
| Recall initiated | 2018-07-18 |
| Classified | 2018-07-20 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2022-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 4,556 cartons |
| Reason classes | cgmp, specification failure |
| NDC | 00904-6594-61, 00904-6595-61 |
| Lot numbers | T-01269, T-01524, T-01646, T-01668, T-01788 |
| Model numbers | 302087 |
Product
Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.
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-0967-2018. 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.