Losartan Pot/HCTZ 50/12 — Class II drug recall D-0894-2022
Terminated recall by Direct Rx, reported 2022-06-01, distributed in FL. CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
| Recall number | D-0894-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Direct Rx, Dawsonville, GA, United States |
| Recall initiated | 2022-05-11 |
| Classified | 2022-05-24 |
| Reported by FDA | 2022-06-01 |
| Terminated | 2022-12-02 |
| Distributed | FL |
| Quantity | 6 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 72189-0297, 72189-0297-90 |
| Lot numbers | 19NO2108, 19NO2114, 22NO2126 |
| Expiration dates | 2025-01-31 |
Product
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
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-0894-2022. 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.