Medications & Supplements/Prescription Drugs

Glenmark Telmisartan and Hydrochlorothiazide Tablets Recalled for Packaging Defect

Agency Publication Date: August 5, 2022

Summary

Glenmark Pharmaceuticals is recalling 72,288 units of Telmisartan and Hydrochlorothiazide tablets (80 mg/25 mg and 80 mg/12.5 mg), which are used to treat high blood pressure. The recall was issued because the blister packaging is difficult to open, causing the tablets to break during removal. While no injuries have been reported, Glenmark has received multiple consumer complaints about the broken medication.

Risk

Tablets that break during removal from packaging may result in a patient receiving an incorrect or inconsistent dose of medication. This can potentially lead to poorly controlled blood pressure or other health complications related to inconsistent drug delivery.

What You Should Do

This recall involves 30-count blister packs of Glenmark Telmisartan and Hydrochlorothiazide Tablets in two strengths: 80 mg/25 mg (NDC 68462-842-13) and 80 mg/12.5 mg (NDC 68462-841-13).
Check the lot number and expiration date printed on your blister pack or pharmacy label to see if your medication is included. See the Affected Products section below for the full list of affected codes.
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 the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

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: Telmisartan and Hydrochlorothiazide Tablets USP (80 mg/25 mg)

Variants: 80 mg/25 mg, 30 Tablets, Rx Only

Lot Numbers:

17210935 (Exp 05/2023)

17210936 (Exp 05/2023)

17211206 (Exp 06/2023)

17211652 (Exp 08/2023)

17211655 (Exp 08/2023)

17211658 (Exp 08/2023)

NDC:

68462-842-13

Manufactured by Glenmark Pharmaceuticals Ltd., India

Product: Telmisartan and Hydrochlorothiazide Tablets USP (80 mg/12.5 mg)

Variants: 80 mg/12.5 mg, 30 Tablets, Rx Only

Lot Numbers:

17210929 (Exp 05/2023)

17210930 (Exp 05/2023)

17211203 (Exp 06/2023)

17211643 (Exp 08/2023)

17211646 (Exp 08/2023)

17211649 (Exp 08/2023)

NDC:

68462-841-13

Manufactured by Glenmark Pharmaceuticals Ltd., India

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90541

Status: Resolved

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 72288 units

Distributed To: Nationwide

Agency Last Updated: February 23, 2023

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

This recall involves 30-count blister packs of Glenmark Telmisartan and Hydrochlorothiazide Tablets in two strengths: 80 mg/25 mg (NDC 68462-842-13) and 80 mg/12.5 mg (NDC 68462-841-13).

Check the lot number and expiration date printed on your blister pack or pharmacy label to see if your medication is included. See the Affected Products section below for the full list of affected codes.

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 the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

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: Telmisartan and Hydrochlorothiazide Tablets USP (80 mg/25 mg)

Variants: 80 mg/25 mg, 30 Tablets, Rx Only

Lot Numbers:

17210935 (Exp 05/2023)

17210936 (Exp 05/2023)

17211206 (Exp 06/2023)

17211652 (Exp 08/2023)

17211655 (Exp 08/2023)

17211658 (Exp 08/2023)

NDC:

68462-842-13

Manufactured by Glenmark Pharmaceuticals Ltd., India

Product: Telmisartan and Hydrochlorothiazide Tablets USP (80 mg/12.5 mg)

Variants: 80 mg/12.5 mg, 30 Tablets, Rx Only

Lot Numbers:

17210929 (Exp 05/2023)

17210930 (Exp 05/2023)

17211203 (Exp 06/2023)

17211643 (Exp 08/2023)

17211646 (Exp 08/2023)

17211649 (Exp 08/2023)

NDC:

68462-841-13

Manufactured by Glenmark Pharmaceuticals Ltd., India