Medications & Supplements/Prescription Drugs

Macleods Pharma Usa Inc: Telmisartan and Hydrochlorothiazide Tablets Recalled for Blend Uniformity Failure

Agency Publication Date: March 14, 2019

Summary

Macleods Pharma USA has recalled approximately 368,311 bottles of Telmisartan and Hydrochlorothiazide tablets, which are used to treat high blood pressure. The recall was initiated because the tablets failed content uniformity specifications, meaning the active ingredients may not be evenly distributed throughout each tablet. This issue affects three different dosage strengths—40mg/12.5mg, 80mg/12.5mg, and 80mg/25mg—distributed nationwide in 30-count bottles. No specific injuries or adverse events have been reported in this data.

Risk

The lack of blend uniformity means some tablets may contain too much or too little of the active medications. This can lead to unpredictable blood pressure control, potentially causing either ineffective treatment or an increased risk of side effects from an overdose of the medication.

What You Should Do

Check your prescription bottle for 'Telmisartan and Hydrochlorothiazide Tablets' and the following NDC numbers: 33342-128-07 (40mg/12.5mg), 33342-129-07 (80mg/12.5mg), or 33342-130-07 (80mg/25mg).
Verify if your lot number and expiration date are included in the recall. For 40mg/12.5mg, check for lots BTL703A through BTL813A with expirations ranging from Feb-19 to Oct-20. For 80mg/12.5mg, check for lots BTM703A through BTM819A with expirations from Feb-19 to Nov-20. For 80mg/25mg, check for lots BTN703A through BTN814A with expirations from Feb-19 to Sep-20.
If you identify your medication as part of the recall, contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement.
Return any unused product to the pharmacy where it was purchased for a refund and contact Macleods Pharma USA for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Telmisartan and Hydrochlorothiazide Tablets (40mg/12.5 mg, 30-count bottles)

Model:

NDC 33342-128-07

Lot Numbers:

BTL703A (Exp. Feb-19)

BTL705A (Exp Apr-19)

BTL706A (Exp May-19)

BTL707A (Exp May-19)

BTL708A (Exp May-19)

BTL709A (Exp Nov-19)

BTL710A (Exp. Dec-19)

BTL711A (Exp. Dec-19)

BTL801A (Exp. Dec-19)

BTL802A (Exp. Feb-20)

BTL803A (Exp. Feb-20)

BTL804A (Exp. Apr-20)

BTL805A (Exp. Apr-20)

BTL807A (Exp May-20)

BTL807B (Exp May-20)

BTL809A (Exp Jul-20)

BTL810A (Exp Jul-20)

BTL811A (Exp Sep-20)

BTL812A (Exp Oct-20)

BTL813A (Exp Oct-20)

Date Ranges: February 2019 - October 2020

Product: Telmisartan and Hydrochlorothiazide Tablets, USP (80mg/12.5 mg, 30-count bottles)

Model:

NDC 33342-129-07

Lot Numbers:

BTM703A (Exp Feb-19)

BTM704A (Exp Feb-19)

BTM706A (Exp Feb-19)

BTM707A (Exp Feb-19)

TM708A (Exp Apr-19)

BTM709A (Exp Apr-19)

BTM710A (Exp Jun-19)

BTM711A (Exp Oct-19)

BTM712A (Exp Oct-19)

BTM713A (Exp Nov-19)

BTM714A (Exp Nov-19)

BTM715A (Exp Nov-19)

BTM801A (Exp Dec-19)

BTM802A (Exp Dec-19)

BTM803A (Exp Dec-19)

BTM804A (Exp Dec-19)

BTM806A (Exp Mar-20)

BTM807A (Exp Mar-20)

BTM809A (Exp Apr-20)

BTM810A (Exp. Jul-20)

BTM811A (Exp. Jul-20)

BTM812A (Exp. Jul-20)

BTM813A (Exp Sep-20)

BTM814A (Exp Sep-20)

BTM815A (Exp Sep-20)

BTM816A (Exp Sep-20)

BTM817A (Exp Sep-20)

BTM818A (Exp Nov-20)

BTM819A (Exp Nov-20)

Date Ranges: February 2019 - November 2020

Product: Telmisartan and Hydrochlorothiazide Tablets (80 mg/25 mg, 30-count bottles)

Model:

NDC 33342-130-07

Lot Numbers:

BTN703A (Exp Feb-19)

BTN704A (Exp Feb-19)

BTN705A (Exp May-19)

BTN706A (Exp May-19)

BTN707A (Exp Jun-19)

BTN810A (Exp Jun-20)

BTN811A (Exp Aug-20)

BTN812A (Exp Aug-20)

BTN813A (Exp Sep-20)

BTN814A (Exp Sep-20)

BTN802A (Exp Dec-19)

BTN802B (Exp Dec-19)

BTN803A (Exp Dec-19)

BTN804A (Exp Dec-19)

BTN805A (Exp Feb-20)

BTN806A (Exp Feb-20)

BTN807A (Exp Feb-20)

BTN807B (Exp Feb-20)

BTN808A (Exp Apr-20)

BTN809A (Exp Jun-20)

Date Ranges: February 2019 - September 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82196

Status: Resolved

Manufacturer: Macleods Pharma Usa Inc

Sold By: Pharmacies

Manufactured In: United States, India

Units Affected: 3 products (93227 bottles; 140,589 bottles; 134495 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your prescription bottle for 'Telmisartan and Hydrochlorothiazide Tablets' and the following NDC numbers: 33342-128-07 (40mg/12.5mg), 33342-129-07 (80mg/12.5mg), or 33342-130-07 (80mg/25mg).

Verify if your lot number and expiration date are included in the recall. For 40mg/12.5mg, check for lots BTL703A through BTL813A with expirations ranging from Feb-19 to Oct-20. For 80mg/12.5mg, check for lots BTM703A through BTM819A with expirations from Feb-19 to Nov-20. For 80mg/25mg, check for lots BTN703A through BTN814A with expirations from Feb-19 to Sep-20.

If you identify your medication as part of the recall, contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement.

Return any unused product to the pharmacy where it was purchased for a refund and contact Macleods Pharma USA for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Telmisartan and Hydrochlorothiazide Tablets (40mg/12.5 mg, 30-count bottles)

Model:

NDC 33342-128-07

Lot Numbers:

BTL703A (Exp. Feb-19)

BTL705A (Exp Apr-19)

BTL706A (Exp May-19)

BTL707A (Exp May-19)

BTL708A (Exp May-19)

BTL709A (Exp Nov-19)

BTL710A (Exp. Dec-19)

BTL711A (Exp. Dec-19)

BTL801A (Exp. Dec-19)

BTL802A (Exp. Feb-20)

BTL803A (Exp. Feb-20)

BTL804A (Exp. Apr-20)

BTL805A (Exp. Apr-20)

BTL807A (Exp May-20)

BTL807B (Exp May-20)

BTL809A (Exp Jul-20)

BTL810A (Exp Jul-20)

BTL811A (Exp Sep-20)

BTL812A (Exp Oct-20)

BTL813A (Exp Oct-20)

Date Ranges: February 2019 - October 2020

Product: Telmisartan and Hydrochlorothiazide Tablets, USP (80mg/12.5 mg, 30-count bottles)

Model:

NDC 33342-129-07

Lot Numbers:

BTM703A (Exp Feb-19)

BTM704A (Exp Feb-19)

BTM706A (Exp Feb-19)

BTM707A (Exp Feb-19)

TM708A (Exp Apr-19)

BTM709A (Exp Apr-19)

BTM710A (Exp Jun-19)

BTM711A (Exp Oct-19)

BTM712A (Exp Oct-19)

BTM713A (Exp Nov-19)

BTM714A (Exp Nov-19)

BTM715A (Exp Nov-19)

BTM801A (Exp Dec-19)

BTM802A (Exp Dec-19)

BTM803A (Exp Dec-19)

BTM804A (Exp Dec-19)

BTM806A (Exp Mar-20)

BTM807A (Exp Mar-20)

BTM809A (Exp Apr-20)

BTM810A (Exp. Jul-20)

BTM811A (Exp. Jul-20)

BTM812A (Exp. Jul-20)

BTM813A (Exp Sep-20)

BTM814A (Exp Sep-20)

BTM815A (Exp Sep-20)

BTM816A (Exp Sep-20)

BTM817A (Exp Sep-20)

BTM818A (Exp Nov-20)

BTM819A (Exp Nov-20)

Date Ranges: February 2019 - November 2020

Product: Telmisartan and Hydrochlorothiazide Tablets (80 mg/25 mg, 30-count bottles)

Model:

NDC 33342-130-07

Lot Numbers:

BTN703A (Exp Feb-19)

BTN704A (Exp Feb-19)

BTN705A (Exp May-19)

BTN706A (Exp May-19)

BTN707A (Exp Jun-19)

BTN810A (Exp Jun-20)

BTN811A (Exp Aug-20)

BTN812A (Exp Aug-20)

BTN813A (Exp Sep-20)

BTN814A (Exp Sep-20)

BTN802A (Exp Dec-19)

BTN802B (Exp Dec-19)

BTN803A (Exp Dec-19)

BTN804A (Exp Dec-19)

BTN805A (Exp Feb-20)

BTN806A (Exp Feb-20)

BTN807A (Exp Feb-20)

BTN807B (Exp Feb-20)

BTN808A (Exp Apr-20)

BTN809A (Exp Jun-20)

Date Ranges: February 2019 - September 2020