Losartan Potassium Tablets — Class II drug recall D-1466-2019
Terminated recall by MAJOR PHARMACEUTICALS, reported 2019-07-17, distributed nationwide. CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished
| Recall number | D-1466-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Recalling firm | MAJOR PHARMACEUTICALS, Livonia, MI, United States |
| Recall initiated | 2019-01-10 |
| Classified | 2019-07-09 |
| Reported by FDA | 2019-07-17 |
| Terminated | 2023-02-19 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 00904-6390-61 |
| Lot numbers | R-00474 |
| Model numbers | 301835 |
| Expiration dates | 2019-07 |
Product
Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
Reason for recall
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
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-1466-2019. 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.