Ciclopirox Gel 0.77% recall
FDA recall D-0002-2025 · initiated Sep 30, 2024
Glenmark Pharmaceuticals Inc., USA recalled Ciclopirox Gel 0.77% in Sep 2024 — an FDA Class III recall (D-0002-2025) because Defective Container: Firm received complaints of broken tube at the seal.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Defective Container: Firm received complaints of broken tube at the seal.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 11,568 tubes
Details
- 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.
- Recalling company
- Glenmark Pharms
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US.
- Initiated
- Sep 30, 2024
- FDA report date
- Oct 9, 2024
Frequently asked
- Was Ciclopirox Gel 0.77% recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Ciclopirox Gel 0.77% in Sep 2024 — an FDA Class III recall (D-0002-2025) because Defective Container: Firm received complaints of broken tube at the seal. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Ciclopirox Gel 0.77% recalled?
- Per the FDA enforcement record, the reason for recall D-0002-2025 was: Defective Container: Firm received complaints of broken tube at the seal.
- Is a recalled Ciclopirox Gel 0.77% dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Ciclopirox Gel 0.77% are affected?
- Distributed: Nationwide in the US.. The recall covers these lots — Lot #s: a) 19242028, Exp. 04/30/2026; b) 19242028, Exp. 04/30/2026; c) 19242028, Exp. 04/30/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0002-2025.