Ciclopirox Gel 0.77% Tubes Recalled Due to Broken Seals
Glenmark Pharmaceuticals is recalling Ciclopirox Gel 0.77% tubes nationwide due to broken seals. The recall affects 11,568 tubes; no illnesses or injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: While this is an FDA Class III recall with no reported illnesses or injuries, the broken tube seals represent a functional packaging defect that compromises product integrity. This precautionary recall is intended to prevent potential contamination or product degradation.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Ciclopirox Gel 0.77%, a prescription dermatologic medication, in 30 gm, 45 gm, and 100 gm tubes. The recall affects products distributed nationwide in the United States.
The recall was initiated due to reports of broken tubes at the seal. This defect could compromise product integrity during storage or handling. The affected lot number is 19242028, which expires on 04/30/2026.
A total of 11,568 tubes have been recalled. No illnesses or injuries have been reported in connection with this defect.
Consumers who have purchased Ciclopirox Gel 0.77% with lot number 19242028 should stop using the product and contact their pharmacy or healthcare provider for guidance on next steps.
The recalled product
- 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 f
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Topical / Dermatologic
- Hazard
- broken-seal
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #s: a) 19242028
- Exp. 04/30/2026
- b) 19242028
- c) 19242028
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27