RecallRadar

FDA Drug recall D-1213-2015

Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Researc…

On 2015-07-15 the FDA classified a Class II recall of Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Researc… by Apotex, citing failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1213-2015
ClassificationClass II
Statusterminated
Initiated2015-05-29
Published2015-07-15
Last updated2026-09-13 11:51 UTC
CompanyApotex
DistributionUS

Product

Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3162-9

Reason

Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

Identifiers

code_infoLot #: KT3819, Exp 11/2015; Lot #: KT3821, Exp 11/2015

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1213-2015%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.