FDA Drug recall D-0838-2022
Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufac…
- FDA Drug
- Class II
- terminated
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class II recall of Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufac… by Lupin Pharmaceuticals, citing CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0838-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-31 |
| Published | 2022-05-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Identifiers
| ndc | 68180-210-09 |
|---|---|
| ndc | 68180-210-03 |
| ndc | 68180-210-01 |
| ndc | 68180-210-06 |
| ndc | 68180-211-06 |
| ndc | 68180-211-09 |
| ndc | 68180-211-03 |
| ndc | 68180-211-01 |
| ndc | 68180-212-06 |
| ndc | 68180-212-03 |
| ndc | 68180-212-09 |
| ndc | 68180-212-01 |
| ndc | 68180-376-03 |
| ndc | 68180-376-06 |
| ndc | 68180-376-01 |
| ndc | 68180-376-09 |
| ndc | 68180-377-03 |
| ndc | 68180-377-01 |
| ndc | 68180-377-09 |
| ndc | 68180-377-06 |
| ndc | 68180-378-09 |
| ndc | 68180-378-03 |
| ndc | 68180-378-06 |
| ndc | 68180-378-01 |
| ndc | 68180-307-01 |
| ndc | 68180-307-02 |
| ndc | 68180-307-09 |
| ndc | 68180-307-06 |
| ndc | 68180-308-06 |
| ndc | 68180-308-09 |
| ndc | 68180-308-02 |
| ndc | 68180-308-01 |
| ndc | 68180-309-06 |
| ndc | 68180-309-09 |
| ndc | 68180-309-02 |
| ndc | 68180-309-01 |
| code_info | H001333, exp. date Nov-22 H002786, exp. date Jan-23 H101282, exp. date Feb-23 H001189, exp. date Nov-22 H002955, ex…H001333, exp. date Nov-22 H002786, exp. date Jan-23 H101282, exp. date Feb-23 H001189, exp. date Nov-22 H002955, exp. date Jan-23 H101285, exp. date Feb-23 H001714, exp. date Dec-22 H000523, exp. date Jan-23 H101989, exp. date Mar-23 H001940, exp. date Dec-22 H003080, exp. date Jan-23 H101789, exp. date Mar-23 H002388, exp. date Jan-23 H100109, exp. date Feb-23 H002389, exp. date Jan-23 H100642, exp. date Feb-23 H000848, exp. date Nov-22, H002002, exp. date Dec-22 H100110, exp. date Feb-23 H001190, exp. date Nov-22 H002003, exp. date Dec-22 H100111, exp. date Feb-23 H001191, exp. date Nov-22 H002489, exp. date Jan-23 H100146, exp. date Feb-23 H001192, exp. date Nov-22 H002390, exp. date Jan-23 H100147, exp. date Feb-23 H001058, exp. date Nov-22 H002486, exp. date Jan-23 H101283, exp. date Feb-23 H000985, exp. date Nov-22 H002487, exp. date Jan-23 H101284, exp. date Feb-23 H001059, exp. date Nov-22 H002488, exp. date Jan-23 H100643, exp. date Feb-23 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0838-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.