RecallRadar

FDA Drug recall D-0892-2022

Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03

On 2022-06-01 the FDA classified a Class II recall of Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03 by Preferred Pharmaceuticals, citing CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0892-2022
ClassificationClass II
Statusterminated
Initiated2022-05-03
Published2022-06-01
Last updated2026-09-13 11:52 UTC
CompanyPreferred Pharmaceuticals
DistributionCA, FL

Product

Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.

Reason

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Identifiers

code_infoLot: K1721E, EXP: 4/30/2023, NDC: 68788-7758-03; Lot: H3021Q, EXP: 2/28/2023, NDC: 68788-7758-03.

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-0892-2022%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.