FDA Drug recall D-0002-2025
Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35
- FDA Drug
- Class III
- ongoing
- Published 2024-10-09
On 2024-10-09 the FDA classified a Class III recall of Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35 by Glenmark Pharmaceuticals Usa, citing defective Container: Firm received complaints of broken tube at the seal.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0002-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-09-30 |
| Published | 2024-10-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
Defective Container: Firm received complaints of broken tube at the seal.
Identifiers
| code_info | Lot #s: a) 19242028, Exp. 04/30/2026; b) 19242028, Exp. 04/30/2026; c) 19242028, Exp. 04/30/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0002-2025%22
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