Medications & Supplements/Prescription Drugs

Glenmark Diltiazem Hydrochloride Capsules Recalled for Dissolution Failure

Agency Publication Date: April 2, 2024

Summary

Glenmark Pharmaceuticals Inc., USA is recalling 6,528 bottles of Diltiazem Hydrochloride Extended-Release Capsules (120 mg) because the medication failed a dissolution test during a routine stability study. When a drug fails this test, it means it may not break down or release the active medicine into the body at the correct rate. Consumers taking this medication should speak with their healthcare provider or pharmacist regarding the recall.

Risk

If the capsules do not dissolve as intended, the patient may not receive the proper amount of medication at the right time. This could potentially interfere with the management of blood pressure or heart rate, leading to therapeutic failure or adverse effects.

What You Should Do

The recalled product is Glenmark Pharmaceuticals Inc., USA Diltiazem Hydrochloride Extended-Release Capsules (USP 120 mg) in 100-count bottles, identified by NDC 68462-562-01 and Lot 17230304 with an expiration date of 12/31/2024.
Check your prescription bottle label for the NDC code 68462-562-01 and the lot number 17230304 to confirm if your medication is included in this recall.
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: Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg

Variants: 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle

Lot Numbers:

17230304 (Exp. 12/31/2024)

NDC:

68462-562-01

Recall #: D-0430-2024

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94280

Status: Active

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Pharmacies

Manufactured In: India

Units Affected: 6,528 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

The recalled product is Glenmark Pharmaceuticals Inc., USA Diltiazem Hydrochloride Extended-Release Capsules (USP 120 mg) in 100-count bottles, identified by NDC 68462-562-01 and Lot 17230304 with an expiration date of 12/31/2024.

Check your prescription bottle label for the NDC code 68462-562-01 and the lot number 17230304 to confirm if your medication is included in this recall.

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.