Perrigo Recalls Ciclopirox Shampoo Due to Stability Testing Failures
Perrigo New York, Inc. is recalling specific lots of Ciclopirox shampoo 1% because stability testing revealed out-of-specification related substances.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates the product is not likely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Perrigo New York, Inc. is recalling 12,252 bottles of Ciclopirox shampoo 1%, 120 mL, prescription only. The product is manufactured by Perrigo in Bronx, NY, and distributed by Perrigo in Allegan, MI. The recall affects specific lots with expiration dates of 02/19.
The recall was initiated due to failed degradation and impurities specifications. Specifically, stability testing identified out-of-specification related substance results. The product was distributed nationwide within the United States.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement. The recall is classified as Class III by the FDA, indicating the product is not likely to cause adverse health consequences.
The recalled product
- Product
- CICLOPIROX (CICLOPIROX)
- Brand
- CICLOPIROX
- Manufacturer
- Perrigo New York, Inc.
- Category
- Drug — Topical Antifungal
- Hazard
- Affected units
- 12,252
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 (3)
- Lot #: 7DT0280
- 7ET0565
- Exp. 02/19
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CICLOPIROX
- LowTaro Recalls Subpotent Ciclopirox Shampoo 1% Prescription Bottles
FDA (Drugs) · 2013-12-18
Same hazard · impurities
See all →- ModerateCipla Recalls Fosfomycin Tromethamine Due to Impurity Specification Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- LowMacleods Recalls Olanzapine Tablets Due to Impurity Levels
FDA (Drugs) · 2026-09-30
Similar recalls
- ModerateCiclopirox shampoo recalled after failing impurity specifications at eighteen months
FDA (Drugs) · 2025-12-24
- LowPerrigo Recalls Salicylic Acid Shampoo Due to Organic Impurity
FDA (Drugs) · 2017-03-08
- LowTaro Recalls Subpotent Ciclopirox Shampoo 1% Prescription Bottles
FDA (Drugs) · 2013-12-18
- ModeratePerrigo Recalls Hydrocortisone Ointment for Failed Stability Specifications
FDA (Drugs) · 2018-05-23
- LowPerrigo Recalls Salicylic Acid Cream Due to Organic Impurity
FDA (Drugs) · 2017-03-08
- ModerateLupin Recalls Suprax Cefixime Oral Suspension Due to Impurity Failure
FDA (Drugs) · 2014-04-09