Losartan Potassium and Hydrochlorothiazide Tablets USP — Class II drug recall D-0842-2022
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-0842-2022 |
|---|---|
| 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 | 303,696 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 | 68180-217-06, 68180-217-09, H001155, H001156, H001355, H001356, H001357, H001358, H001359, H001371, H001372, H001373, H001374, H001375, H001627, H001628, H001629, H001630, H001645, H001646, H001647, H001798, H001799, H001882, H001883, H001947, H001948, H001949, H001985, H001986, H001987, H001988, H001989, H001990, H002242, H002243, H002244, H002245, H002315, H002316 and 105 more |
Product
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), 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-0842-2022. 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.