FDA Drug recall D-0840-2022
Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufa…
- 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, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufa… 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-0840-2022 |
| 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, 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
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 | H903573, exp. date Oct-22 H002311, exp. date Dec-22 H100713, exp. date Mar-23 H001060, exp. date Nov-22 H002620, ex…H903573, exp. date Oct-22 H002311, exp. date Dec-22 H100713, exp. date Mar-23 H001060, exp. date Nov-22 H002620, exp. date Jan-23 H100714, exp. date Mar-23 H001456, exp. date Nov-22 H002313, exp. date Jan-23 H100934, exp. date Mar-23 H001457, exp. date Nov-22 H002490, exp. date Jan-23 H100935, exp. date Mar-23 H001470,, exp. date Nov-22 H002842, exp. date Jan-23 H101081, exp. date Mar-23 H001484, exp. date Dec-22 H002843, exp. date Jan-23 H101148, exp. date Mar-23 H001485, exp. date Dec-22 H002995, exp. date Jan-23 H101639, exp. date Mar-23 H001708, exp. date Dec-22 H003199, exp. date Feb-23 H101480, exp. date Mar-23 H002314, exp. date Dec-22 H003200, exp. date Feb-23 H101822, exp. date Mar-23 H001709, exp. date Dec-22 H100028, exp. date Feb-23 H101481, exp. date Mar-23 H002001, exp. date Dec-22 H100712, exp. date Feb-23 H102288, exp. date Mar-23 H001991, exp. date Dec-22 H100221, exp. date Feb-23 H002000, exp. date Dec-22 H100222, exp. dateFeb-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-0840-2022%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.