RecallRadar

FDA Drug recall D-0788-2022

Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG b…

On 2022-05-04 the FDA classified a Class II recall of Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG b… by Remedyrepack, citing CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0788-2022
ClassificationClass II
Statusterminated
Initiated2022-04-06
Published2022-05-04
Last updated2026-09-13 11:52 UTC
CompanyRemedyrepack
DistributionAK, PA

Product

Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.

Reason

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

Identifiers

ndc70518-3282-0
ndc70518-3282-1
ndc70518-3282-2
code_infoLot # B1467803-120621, exp. date 06/30/2022 Lot # J0585793-121721, exp. date 12/31/2022

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-0788-2022%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.