FDA Drug recall D-0032-2021
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc
- FDA Drug
- Class II
- terminated
- Published 2020-10-07
On 2020-10-07 the FDA classified a Class II recall of Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc by Direct Rx, citing CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0032-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-12 |
| Published | 2020-10-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Direct Rx |
| Distribution | FL |
Product
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
Reason
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Identifiers
| code_info | Lot: 12DE1806 Exp. 01/31/2021 |
|---|
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-0032-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.