Why it was recalled
Defective Container: Firm received complaints of broken tube at the seal.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #s: a) 19242028, Exp. 04/30/2026; b) 19242028, Exp. 04/30/2026; c) 19242028, Exp. 04/30/2026
Where it was sold
Nationwide in the US.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0002-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Sep 30, 2024
- FDA report date
- Oct 9, 2024
- Quantity
- 11,568 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0002-2025, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95444
- Address
- 750 Corporate Dr
- Code information
- Lot #s: a) 19242028, Exp. 04/30/2026; b) 19242028, Exp. 04/30/2026; c) 19242028, Exp. 04/30/2026
- Postal code
- 07430-2009
- Report date
- Oct 9, 2024
- Product type
- Drugs
- Recall number
- D-0002-2025
- Classification
- Class III
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 11,568 tubes
- Reason for recall
- Defective Container: Firm received complaints of broken tube at the seal.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the US.
- Recall initiation date
- Sep 30, 2024
- Center classification date
- Oct 2, 2024