Class II · Moderate risk
Ciclopirox Shampoo
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Ciclopirox Gel 0.77%
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective Container: Firm received complaints of broken tube at the seal.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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.
Affected NDCs
68462-0455-35
68462-0455-47
68462-0455-94
Compare with the code on your package — it is the most precise check available.
Drug: Ciclopirox
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| ciclopirox NDC 68462-0455 |
7.7 mg/g | Gel Topical |
Glenmark Pharmaceuticals Inc., USA | Rx |
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- NDC code
- 68462-0455-35
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0002-2025 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Ciclopirox recalls
See all
Class II · Moderate risk
Ciclopirox Topical Solution 8%
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk
Ciclopirox shampoo 1%
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Class III · Low risk
Ciclopirox Olamine Cream USP
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Class III · Low risk
Ciclopirox Olamine Cream USP
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Other recalls by Glenmark Pharmaceuticals Inc., USA
All 2024 recalls
Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Class II · Moderate risk
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Class II · Moderate risk
Ondansetron Orally Disintegrating Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
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