FDA Drug recall D-0842-2022
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 6818…
- FDA Drug
- Class II
- terminated
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class II recall of Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 6818… 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-0842-2022 |
| 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 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
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Identifiers
| ndc | 68180-215-09 |
|---|---|
| ndc | 68180-215-03 |
| ndc | 68180-215-01 |
| ndc | 68180-215-06 |
| ndc | 68180-216-06 |
| ndc | 68180-216-09 |
| ndc | 68180-216-01 |
| ndc | 68180-216-03 |
| ndc | 68180-217-06 |
| ndc | 68180-217-09 |
| ndc | 68180-217-01 |
| ndc | 68180-217-03 |
| code_info | Lot # H001156 4/30/2022 68180-217-06 H001627 5/31/2022 68180-217-06 H001947 6/30/2022 68180-217-06 H002242 8/31/202…Lot # H001156 4/30/2022 68180-217-06 H001627 5/31/2022 68180-217-06 H001947 6/30/2022 68180-217-06 H002242 8/31/2022 68180-217-06 H101826 7/31/2023 68180-217-06 H001155 4/30/2022 68180-217-09 H001355 5/31/2022 68180-217-09 H001356 5/31/2022 68180-217-09 H001357 5/31/2022 68180-217-09 H001358 5/31/2022 68180-217-09 H001359 5/31/2022 68180-217-09 H001371 5/31/2022 68180-217-09 H001372 5/31/2022 68180-217-09 H001373 5/31/2022 68180-217-09 H001374 5/31/2022 68180-217-09 H001375 5/31/2022 68180-217-09 H001628 5/31/2022 68180-217-09 H001629 5/31/2022 68180-217-09 H001630 6/30/2022 68180-217-09 H001645 6/30/2022 68180-217-09 H001646 6/30/2022 68180-217-09 H001647 6/30/2022 68180-217-09 H001798 6/30/2022 68180-217-09 H001799 6/30/2022 68180-217-09 H001882 6/30/2022 68180-217-09 H001883 6/30/2022 68180-217-09 H001948 6/30/2022 68180-217-09 H001949 6/30/2022 68180-217-09 H001985 6/30/2022 68180-217-09 H001986 6/30/2022 68180-217-09 H001987 7/31/2022 68180-217-09 H |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0842-2022%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.