Losartan Potassium and Hydrochlorothiazide Tablets USP — Class II drug recall D-0841-2022
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-0841-2022 |
|---|---|
| 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 | 1,214,016 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 | 68180-215-06, 68180-215-09, H001149, H001150, H001151, H001152, H001532, H001533, H001534, H001535, H001536, H001602, H001603, H001604, H001605, H001606, H001607, H001608, H001884, H001885, H001886, H001887, H001888, H002171, H002172, H002173, H002174, H002175, H002539, H002540, H002541, H002542, H002543, H002544, H002545, H002976, H002977, H002978, H003131, H003132 and 45 more |
Product
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), 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-0841-2022. 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.