Losartan Potassium Tablets USP — Class II drug recall D-0840-2022
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-0840-2022 |
|---|---|
| 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 | 1,247,067 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 68180-0210, 68180-0210-01, 68180-0210-03, 68180-0210-06, 68180-0210-09, 68180-0211, 68180-0211-01, 68180-0211-03, 68180-0211-06, 68180-0211-09, 68180-0212, 68180-0212-01, 68180-0212-03, 68180-0212-06, 68180-0212-09, 68180-0307, 68180-0307-01, 68180-0307-02, 68180-0307-06, 68180-0307-09, 68180-0308, 68180-0308-01, 68180-0308-02, 68180-0308-06, 68180-0308-09 and 20 more |
Product
Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), 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-0840-2022. 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.