Ciclopirox Gel 0 — Class III drug recall D-0002-2025
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2024-10-09, distributed nationwide. Defective Container: Firm received complaints of broken tube at the seal.
| Recall number | D-0002-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2024-09-30 |
| Classified | 2024-10-02 |
| Reported by FDA | 2024-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 11,568 tubes |
| Reason classes | packaging |
| NDC | 68462-0455-35, 68462-0455-47, 68462-0455-94 |
| Expiration dates | 2026-04-30 |
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.
Reason for recall
Defective Container: Firm received complaints of broken tube at the seal.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0002-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.