FDA Drug recall D-1281-2019
Losartan Potassium Tab
- FDA Drug
- Class II
- terminated
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class II recall of Losartan Potassium Tab by Preferred 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-1281-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-30 |
| Published | 2019-05-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Preferred Pharmaceuticals |
| Distribution | CA, GA, IN, VA |
Product
Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ
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 | a) 30 tablets: lot A1818G batch 01181807 exp 3/2020; b) 90 tablets: lot L0517L batch 12051712 exp 3/2020 |
|---|
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-1281-2019%22
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