FDA Drug recall D-0891-2022
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09
- FDA Drug
- Class II
- terminated
- Published 2022-06-01
On 2022-06-01 the FDA classified a Class II recall of Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09 by Preferred 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-0891-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-03 |
| Published | 2022-06-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Preferred Pharmaceuticals |
| Distribution | CA, FL |
Product
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.
Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Identifiers
| code_info | Lot: K1721D, EXP: 4/30/2023, NDC: 68788-7758-09; Lot: K1021E, EXP: 7/31/2023, NDC: 68788-7758-09. |
|---|
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-0891-2022%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.