FDA Drug recall D-1466-2019
Losartan Potassium Tablets, USP. 50 mg
- FDA Drug
- Class II
- terminated
- Published 2019-07-17
On 2019-07-17 the FDA classified a Class II recall of Losartan Potassium Tablets, USP. 50 mg by Major Pharmaceuticals, citing 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 manuf….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1466-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-10 |
| Published | 2019-07-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Major Pharmaceuticals |
| Distribution | US |
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
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
Identifiers
| code_info | Major Label Unit Does 10 x 10 Cartons, Major Item # 301835. Lot Number: R-00474. Expiration date: 07/2019. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1466-2019%22
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