Losartan Potassium and Hydrochlorothiazide Tablets USP — Class II drug recall D-0843-2022
Terminated recall by Lupin Pharmaceuticals Inc., reported 2022-05-11, distributed nationwide. CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
| Recall number | D-0843-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2022-03-31 |
| Classified | 2022-05-03 |
| Reported by FDA | 2022-05-11 |
| Terminated | 2023-05-22 |
| Distributed | Nationwide (US) |
| Quantity | 2,361,924 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 68180-0215, 68180-0215-01, 68180-0215-03, 68180-0215-06, 68180-0215-09, 68180-0216, 68180-0216-01, 68180-0216-03, 68180-0216-06, 68180-0216-09, 68180-0217, 68180-0217-01, 68180-0217-03, 68180-0217-06, 68180-0217-09 |
| Lot numbers | 68180-216-06, 68180-216-09, H001600, H001601, H001625, H001626, H001794, H001795, H001796, H001797, H001878, H001879, H001880, H001881, H001942, H001943, H001944, H001945, H001946, H002178, H002179, H002180, H002181, H002182, H002183, H002237, H002238, H002239, H002240, H002241, H002626, H002627, H002628, H002629, H002630, H002631, H002979, H002980, H002981, H002982 and 58 more |
Product
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
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-0843-2022. 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.