Medications & Supplements/Topical Products

Glenmark Ciclopirox Gel 0.77% Recalled for Defective Tubes

Agency Publication Date: October 2, 2024

Summary

Glenmark Pharmaceuticals Inc., USA is recalling 11,568 tubes of Ciclopirox Gel 0.77%, a prescription antifungal medication used for skin conditions. The recall was initiated because the manufacturer received complaints that the product tubes were breaking at the seal. The affected products include the 30 gram, 45 gram, and 100 gram sizes from a specific production lot with an expiration date of April 2026.

Risk

A broken seal on the tube can cause the medication to leak or be exposed to air and contaminants. This defect may compromise the sterility and effectiveness of the medication, potentially leading to inadequate treatment of skin conditions.

What You Should Do

This recall affects Glenmark Pharmaceuticals Ciclopirox Gel 0.77% (30g, 45g, or 100g tubes) from lot number 19242028 with an expiration date of 04/30/2026.
Check the packaging for NDC codes 68462-0455-35 (30 gram size), 68462-0455-47 (45 gram size), or 68462-0455-94 (100 gram size).
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.
Contact Glenmark Pharmaceuticals Inc., USA directly for further instructions regarding this recall.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report an issue.

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: Ciclopirox Gel 0.77%by Glenmark

Variants: 30 gm Tube, 45 gm Tube, 100 gm Tube, Topical Gel

Lot Numbers:

19242028 (Exp. 04/30/2026)

NDC:

68462-0455-35

68462-0455-47

68462-0455-94

Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430 by Glenmark Pharmaceuticals, Ltd., Goa, India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95444

Status: Active

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 11,568 tubes

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 Glenmark Pharmaceuticals Ciclopirox Gel 0.77% (30g, 45g, or 100g tubes) from lot number 19242028 with an expiration date of 04/30/2026.

Check the packaging for NDC codes 68462-0455-35 (30 gram size), 68462-0455-47 (45 gram size), or 68462-0455-94 (100 gram size).

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.

Contact Glenmark Pharmaceuticals Inc., USA directly for further instructions regarding this recall.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report an issue.