CLASS II Drug recall · Reported 20 Mar 2019 · FDA Enforcement Report

Telmisartan and Hyrdochlorothiazide Tablets recalled

Macleods Pharma Usa is recalling Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun, distributed nationwide in the US. The recall was initiated on 25 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 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.

Quantity recalled140,589 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1004-2019
FDA event ID: 82196
Recalling firm: Macleods Pharma Usa, Plainsboro, NJ
Classification: Class II
Status: Terminated
Recall initiated: 25 Feb 2019
FDA classified: 14 Mar 2019
Reported: 20 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Pressure Medication

Timeline

25 Feb 2019	Recall initiated by company
14 Mar 2019	Classified by FDA	+17 days
20 Mar 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 82196

This product is part of a recall event; the main page for the event is Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg recalled.

Reported	Class	Recall	Company	Reason	Where
20 Mar 2019	CLASS II	Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg recalled	Macleods Pharma Usa	Potency & Assay	Nationwide
20 Mar 2019	CLASS II	Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg recalled	Macleods Pharma Usa	Potency & Assay	Nationwide

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Other Telmisartan recalls

All 11

Reported	Class	Recall	Company	Reason	Where
20 Mar 2024Drug	CLASS II	Telmisartan Tablets, USP 40mg recalled by Micro Labs	Micro Labs	Potency & Assay	PR, RI, TN
17 Aug 2022Drug	CLASS II	Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg recalledTelmisartan And Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	Other	Nationwide
17 Aug 2022Drug	CLASS II	Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg recalledTelmisartan And Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	Other	Nationwide
22 Dec 2021Drug	CLASS III	Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg recalled	Torrent Pharma	Potency & Assay	Nationwide
14 Apr 2021Drug	CLASS I	Telmisartan Tablets, USP 20 mg recalled by Alembic PharmaceuticalsTelmisartan	Alembic Pharmaceuticals	Packaging Defects	Nationwide