Class IIIOngoing

Ciclopirox Gel 0.77% recall

FDA recall D-0002-2025 · initiated Sep 30, 2024

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Defective Container: Firm received complaints of broken tube at the seal.

Details

Product: Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Recalling company: Glenmark Pharms
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the US.
Initiated: Sep 30, 2024
FDA report date: Oct 9, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0002-2025 ↗

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