Losartan Pot — Class II drug recall D-0971-2022
Terminated recall by Direct Rx, reported 2022-06-08, distributed in AL, FL, GA, LA. CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
| Recall number | D-0971-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Direct Rx, Dawsonville, GA, United States |
| Recall initiated | 2022-05-05 |
| Classified | 2022-05-27 |
| Reported by FDA | 2022-06-08 |
| Terminated | 2023-10-05 |
| Distributed | AL, FL, GA, LA |
| Quantity | 81 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 72189-0012, 72189-0012-90, 72189-0098, 72189-0098-90, 72189-0129, 72189-0129-30, 72189-0129-90, 72189-0139, 72189-0139-30, 72189-0139-90, 72189-0167, 72189-0167-30, 72189-0167-90 |
| Lot numbers | 05JA2106, 11MY2103, 13SE2113, 20MY2115, 22JU2118, 29JY2113 |
| Expiration dates | 2022-06-30, 2022-11-30, 2022-12-31, 2023-02-28 |
Product
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
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-0971-2022. 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.