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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Glenmark Diltiazem Hydrochloride Capsules Recalled for Failed Dissolution

Agency Publication Date: April 25, 2024
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Summary

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling approximately 3,264 bottles of Diltiazem Hydrochloride Extended-Release Capsules, USP (120 mg). This medication, which is used to treat high blood pressure and chest pain, is being recalled because it failed dissolution specifications during quality testing. Consumers who are currently taking this medication should contact their healthcare provider or pharmacist for further guidance.

Risk

If a medication fails to dissolve as specified, the drug may not be absorbed correctly by the body. This can result in the medication being less effective at managing heart conditions and blood pressure.

What You Should Do

  1. This recall involves 100-count bottles of Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg (NDC 68462-562-01) intended for twice-a-day dosage.
  2. Check your medication bottle for lot number 17221312 with an expiration date of 5/31/2024.
  3. 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.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 mgby Glenmark Pharmaceuticals Inc., USA
Variants: 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only
Lot Numbers:
17221312 (Exp. 5/31/2024)
NDC:
68462-562-01

Manufactured for Glenmark Pharmaceuticals Inc., USA. Product of India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94440
Status: Active
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: Pharmacies
Manufactured In: India
Units Affected: 3,264 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 ยท 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.