FDA Drug recall D-1004-2019

Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc

FDA Drug
Class II
terminated
Published 2019-03-20

On 2019-03-20 the FDA classified a Class II recall of Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc by Macleods Pharma Usa, citing failed Content Uniformity Specifications: The product is out of specification for blend uniformity.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1004-2019
Classification	Class II
Status	terminated
Initiated	2019-02-25
Published	2019-03-20
Last updated	2026-09-13 11:52 UTC
Company	Macleods Pharma Usa
Distribution	US

Product

Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Imachal Pradesh, India NDC 33342-129-07

Reason

Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.

Identifiers

code_info	Lot #: BTM703A, BTM704A, BTM706A, BTM707A, Exp Feb-19; TM708A,BTM709A, Exp Apr-19; BTM710A, Exp Jun-19; BTM711A, BTM712… Lot #: BTM703A, BTM704A, BTM706A, BTM707A, Exp Feb-19; TM708A,BTM709A, Exp Apr-19; BTM710A, Exp Jun-19; BTM711A, BTM712A, Exp Oct-19; BTM713A,BTM714A, BTM715A, Exp Nov-19; BTM801A, BTM802A, BTM803A, BTM804A, Exp Dec-19; BTM806A,BTM807A, Exp Mar-20; BTM809A Exp Apr-20; BTM810A, BTM811A, BTM812A, Exp. Jul-20; BTM813A, BTM814A, BTM815A, BTM816A, BTM817A, Exp Sep-20; BTM818A, BTM819A Exp Nov-20.

code_info

Lot #: BTM703A, BTM704A, BTM706A, BTM707A, Exp Feb-19; TM708A,BTM709A, Exp Apr-19; BTM710A, Exp Jun-19; BTM711A, BTM712…

Lot #: BTM703A, BTM704A, BTM706A, BTM707A, Exp Feb-19; TM708A,BTM709A, Exp Apr-19; BTM710A, Exp Jun-19; BTM711A, BTM712A, Exp Oct-19; BTM713A,BTM714A, BTM715A, Exp Nov-19; BTM801A, BTM802A, BTM803A, BTM804A, Exp Dec-19; BTM806A,BTM807A, Exp Mar-20; BTM809A Exp Apr-20; BTM810A, BTM811A, BTM812A, Exp. Jul-20; BTM813A, BTM814A, BTM815A, BTM816A, BTM817A, Exp Sep-20; BTM818A, BTM819A Exp Nov-20.

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-1004-2019%22

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