Recalls / Class III

Class IIID-0002-2025

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.

Affected lot / code info

Lot #s: a) 19242028, Exp. 04/30/2026; b) 19242028, Exp. 04/30/2026; c) 19242028, Exp. 04/30/2026

Why it was recalled

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

Recalling firm

Firm

Glenmark Pharmaceuticals Inc., USA

Notification channel

N/A

Type

Voluntary: Firm initiated

Address

750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009

Distribution

Quantity

11,568 tubes

Distribution pattern

Nationwide in the US.

Timeline

Recall initiated

2024-09-30

FDA classified

2024-10-02

Posted by FDA

2024-10-09

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0002-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.