Use caution Drug recall · FDA · Published February 25, 2019

Macleods Pharma Recalls Telmisartan Tablets Due to Uniformity Issues

Macleods Pharma USA recalls specific lots of Telmisartan and Hydrochlorothiazide tablets because they failed content uniformity specifications.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1005-2019Drug Macleods Pharma ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmMacleods Pharma Usa Inc666 Plainsboro Rd Bldg 200 Ste 230 · Plainsboro, NJ 08536-0009

✎ GovInfoNow plain-language explainer

Macleods Pharma USA is recalling specific lots of Telmisartan and Hydrochlorothiazide Tablets 80 mg/25 mg in 30-count bottles. The recall was initiated because the product failed to meet blend uniformity specifications, meaning the drug content may not be consistent throughout the bottle. This could result in patients receiving doses that are too low or too high. Read more at govinfonow.com/recall/39152-macleods-pharma-recalls-telmisartan-tablets-due-to-uniformity-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/39152-macleods-pharma-recalls-telmisartan-tablets-due-to-uniformity-issues · Updated October 11, 2026 · FDA enforcement record: FDA #D-1005-2019

Cite this page

“Macleods Pharma Recalls Telmisartan Tablets Due to Uniformity Issues.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39152-macleods-pharma-recalls-telmisartan-tablets-due-to-uniformity-issues. Based on FDA recall #D-1005-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1005-2019%22&limit=1).

The Food and Drug Administration announced on Feb. 25, 2019, that Macleods Pharma USA Inc. is recalling Telmisartan/Hydrochlorothiazide Tablets due to failed content uniformity specifications. The agency classified the recall as Class II.

How to tell if you have it

Brand: Macleods Pharma
Product: Telmisartan/Hydrochlorothiazide Tablets 80 mg/25 mg, 30-count bottles
NDC: 33342-130-07
Lot codes: BTN703A, BTN704A (Exp Feb-19); BTN705A, BTN706A (Exp May-19); BTN707A (Exp Jun-19); BTN810A (Exp Jun-20); BTN811A, BTN812A (Exp Aug-20); BTN813A, BTN814A (Exp Sep-20); BTN802A, BTN802B, BTN803A, BTN804A (Exp Dec-19); BTN805A, BTN806A, BTN807A, BTN807B (Exp Feb-20); BTN808A (Exp Apr-20); BTN809A, BTN810A (Exp Jun-20); BTN811A, BTN812A (Exp Aug-20); BTN813A, BTN814A (Exp Sep-20)
Units affected: 134,495 bottles
Distribution: Nationwide within the United States

The hazard

The product is out of specification for blend uniformity, according to the FDA. This failure in content uniformity specifications constitutes the hazard.

Context

GovInfoNow's records show Macleods Pharma USA, Inc. has 20 other recalls on record since Dec. 24, 2015. Other recent recalls of similar products include Macleods Levothyroxine Tablets Recall (Feb. 26, 2026), Macleods Losartan/HCTZ Recall (May 7, 2024), and Macleods Pharma Levofloxacin Tablets Recall (Jan. 5, 2023). Other recent recalls of similar products include Meclizine 12.5mg Tablets Recall (March 16, 2026), Preferred Pharma Recalls Lidocaine Ointment Due to Content Issues (Sept. 28, 2026), and Shoolin Pharma Chem Sildenafil Recall (Aug. 3, 2026).

How to tell if you have this one

Check your medication bottles for the NDC number 33342-130-07 and look for lot numbers including BTN703A, BTN704A, BTN705A, BTN706A, BTN707A, BTN810A, BTN811A, BTN812A, BTN813A, BTN814A, BTN802A, BTN802B, BTN803A, BTN804A, BTN805A, BTN806A, BTN807A, BTN807B, BTN808A, BTN809A. Verify the expiration dates associated with these lots: Feb-19, May-19, Jun-19, Aug-20, Sep-20, Dec-19, Feb-20, Apr-20.

Brand
Macleods Pharma
Category
Drug

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide within the United States

Recall number	Product, codes & lots	Quantity
D-1003-2019	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; 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	93227 bottles
D-1004-2019	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; 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.	140,589 bottles
D-1005-2019	Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-130-07; Lot #: BTN703A, BTN704A Exp Feb-19; BTN705A, BTN706A, Exp May-19; BTN707A, Exp Jun-19; BTN810A, Exp Jun-20; BTN811A, BTN812A Exp Aug-20; BTN813A, BTN814A, Exp Sep-20; BTN802A, BTN802B, BTN803A, BTN804A, Exp Dec-19; BTN805A, BTN806A, BTN807A, BTN807B, Exp Feb-20; BTN808A, Exp Apr-20; BTN809A, BTN810A, Exp Jun-20; BTN811A, BTN812A, Exp Aug-20; BTN813A, BTN814A, Exp Sep-20.	134495 bottles

Based on the official FDA remedy

What to do — step by step

Contact Your Pharmacist
If you have the recalled product, contact your pharmacist or healthcare provider to discuss returning the medication and obtaining a replacement.
Do Not Stop Medication Abruptly
Consult your doctor before making any changes to your medication regimen to ensure your health condition is managed safely during the transition.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Feb 25, 2019Firm started the recall
Mar 14, 2019FDA classified it Class II
Mar 20, 2019Published in FDA’s Enforcement Report
Jul 12, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Where was this product sold?

The product was distributed nationwide within the United States.

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Link to this recall

<a href="https://govinfonow.com/recall/39152-macleods-pharma-recalls-telmisartan-tablets-due-to-uniformity-issues">Macleods Pharma Recalls Telmisartan Tablets Due to Uniformity Issues (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1005-2019 (February 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1005-2019 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.