Medications & Supplements/Prescription Drugs

Glenmark Bisoprolol and Hydrochlorothiazide Tablets Recalled for Impurities

Agency Publication Date: November 2, 2023

Summary

Glenmark Pharmaceuticals Inc., USA has recalled 480 bottles of Bisoprolol Fumarate and Hydrochlorothiazide (5mg/6.25mg) tablets because they failed to meet safety specifications for impurities and degradation. This prescription medication is used to treat high blood pressure. No injuries or adverse health effects have been reported in connection with this recall.

Risk

The medication may contain impurities or have broken down (degraded) over time, which could potentially reduce the effectiveness of the drug or pose unknown health risks to consumers.

What You Should Do

This recall affects 100-count bottles of Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP (5mg/6.25mg) identified by NDC 68462-879-01 and lot number 17212352 with an expiration date of 11/31/2023.
If you have health concerns, contact your healthcare provider or pharmacist.
Return any unused product to the place of purchase for a refund, throw it away, or contact Glenmark Pharmaceuticals Inc., USA for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP (100-count Bottle)

Variants: 5mg/6.25mg, Tablet

Lot Numbers:

17212352 (Exp 11/31/2023)

NDC:

68462-879-01

Manufactured by Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh, India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93252

Status: Resolved

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 480 100-count bottles

Distributed To: Nationwide

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

This recall affects 100-count bottles of Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP (5mg/6.25mg) identified by NDC 68462-879-01 and lot number 17212352 with an expiration date of 11/31/2023.

If you have health concerns, contact your healthcare provider or pharmacist.

Return any unused product to the place of purchase for a refund, throw it away, or contact Glenmark Pharmaceuticals Inc., USA for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.