RecallRadar

FDA Drug recall D-0498-2024

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, I…

On 2024-05-22 the FDA classified a Class II recall of Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, I… by Macleods Pharma Usa, citing presence of foreign substance: plastic-like substance.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0498-2024
ClassificationClass II
Statusongoing
Initiated2024-05-07
Published2024-05-22
Last updated2026-09-13 11:52 UTC
CompanyMacleods Pharma Usa
DistributionUS

Product

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44

Reason

Presence of foreign substance: plastic-like substance.

Identifiers

ndc33342-050-07
ndc33342-050-10
ndc33342-050-44
ndc33342-050-12
ndc33342-051-07
ndc33342-051-10
ndc33342-051-44
ndc33342-051-12
ndc33342-052-07
ndc33342-052-10
ndc33342-052-44
ndc33342-052-12
code_infoLot #: BLK2304A, Exp. 07/31/2025

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0498-2024%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.