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

Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg recalled

Macleods Pharma Usa is recalling Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 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 #: BTL703A, Exp. Feb-19; BTL705A, Exp Apr-19; BTL706A, BTL707A, BTL708A, Exp May-19; BTL709A, Exp Nov-19; BTL710A, BTL711A, BTL801A, Exp. Dec-19; BTL802A, BTL803A, Exp.Feb-20; BTL804A, BTL805A, Exp. Apr-20; BTL807A, BTL807B, Exp May- 20; BTL809A, BTL810A, Exp Jul-20; BTL811A, Exp Sep-20; BTL812A, BTL813A Exp Oct-20

Quantity recalled93227 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-1003-2019
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 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Is Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg recalled?

Yes. Macleods Pharma Usa recalled Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg on 25 Feb 2019. The recall is Class II and its status is Terminated. Recall number D-1003-2019.

Why was it recalled?

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

Which lots are affected?

Lot #: BTL703A, Exp. Feb-19; BTL705A, Exp Apr-19; BTL706A, BTL707A, BTL708A, Exp May-19; BTL709A, Exp Nov-19; BTL710A, BTL711A, BTL801A, Exp. Dec-19; BTL802A, BTL803A, Exp.Feb-20; BTL804A, BTL805A, Exp. Apr-20; BTL807A, BTL807B, Exp May- 20; BTL809A, BTL810A, Exp Jul-20; BTL811A, Exp Sep-20; BTL812A, BTL813A Exp Oct-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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Telmisartan and hyrdochlorothiazide recalls

All 3

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