FDA Drug recall D-1051-2019
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Tor…
- FDA Drug
- Class II
- terminated
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Tor… by Preferred Pharmaceuticals, citing CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1051-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-06 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Preferred Pharmaceuticals |
| Distribution | CA, GA, IN |
Product
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.
Reason
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Identifiers
| code_info | Count, lots, expiry: a) 30-count bottle C2218C, exp 9/2020, D1318E, exp 10/2020; b) 90-count bottle C2719J, exp 9/2020, E1818B, exp 10/2020. |
|---|
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-1051-2019%22
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