CLASS III ONGOING Drug recall · Reported 9 Oct 2024 · FDA Enforcement Report
Ciclopirox Gel 77%, For Dermatologic Use Only, Not for Use in Eyes recalled
Glenmark Pharmaceuticals Inc., U is recalling Ciclopirox Gel 77%, For Dermatologic Use Only, Not for Use in Eyes, distributed nationwide in the US. The recall was initiated on 30 Sep 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0002-2025
- FDA event ID
- 95444
- Recalling firm
- Glenmark Pharmaceuticals Inc., U, Mahwah, NJ
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 30 Sep 2024
- FDA classified
- 2 Oct 2024
- Reported
- 9 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 30 Sep 2024 | Recall initiated by company | |
| 2 Oct 2024 | Classified by FDA | +2 days |
| 9 Oct 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: Firm received complaints of broken tube at the seal.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the US.
Questions about this recall
Is Ciclopirox Gel 77%, For Dermatologic Use Only, Not for Use in Eyes recalled?
Yes. Glenmark Pharmaceuticals Inc., U recalled Ciclopirox Gel 77%, For Dermatologic Use Only, Not for Use in Eyes on 30 Sep 2024. The recall is Class III and its status is Ongoing. Recall number D-0002-2025.
Why was it recalled?
Defective Container: Firm received complaints of broken tube at the seal.
Which lots are affected?
Lot #s: a) 19242028, Exp. 04/30/2026; b) 19242028, Exp. 04/30/2026; c) 19242028, Exp. 04/30/2026
Where was it sold?
Nationwide in the US.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., U | Packaging Defects | Nationwide |
Other Ciclopirox recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Ciclopirox shampoo recalled by Perrigo New YorkCiclopirox | Perrigo New York | Potency & Assay | Nationwide |
| Drug | CLASS III | Ciclopirox Shampoo recalled by Taro Pharmaceuticals U.S.ACiclopirox | Taro Pharmaceuticals U.S.A | Potency & Assay | Nationwide |