Losartan Pot/HCTZ 50/12 — Class II drug recall D-0032-2021
Terminated recall by Direct Rx, reported 2020-10-07, distributed in FL. CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
| Recall number | D-0032-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Direct Rx, Dawsonville, GA, United States |
| Recall initiated | 2019-03-12 |
| Classified | 2020-10-12 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2021-09-21 |
| Distributed | FL |
| Quantity | 33 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 61919-0040-90 |
| Lot numbers | 12DE1806 |
| Expiration dates | 2021-01-31 |
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 for recall
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
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-0032-2021. 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.