Medications & Supplements/Prescription Drugs

Perrigo New York, Inc.: Ciclopirox Shampoo Recalled Due to Impurities and Degradation

Agency Publication Date: February 20, 2019

Summary

Perrigo New York, Inc. is recalling 12,252 bottles of Ciclopirox Shampoo 1% (120 mL) due to the presence of impurities found during stability testing. This prescription-only medicated shampoo was distributed nationwide within the United States. Consumers who have this product should check their lot numbers immediately as the shampoo may no longer meet quality and safety specifications.

Risk

The product failed degradation and impurity tests, meaning the chemical composition of the medication has changed over time. This can reduce the effectiveness of the treatment or potentially expose users to unexpected byproducts of the drug's breakdown.

What You Should Do

Locate your 120 mL bottle of Ciclopirox shampoo 1% and check the label for lot numbers 7DT0280 or 7ET0565 with an expiration date of 02/19.
If your bottle matches these lot numbers and expiration date, stop using the product immediately.
Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse effects.
Return any unused product to your pharmacy to request a refund and contact Perrigo New York, Inc. for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ciclopirox shampoo 1% (120 mL bottle)

Model:

45802-401-09

Lot Numbers:

7DT0280 (Exp. 02/19)

7ET0565 (Exp. 02/19)

Date Ranges: Exp. 02/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82127

Status: Resolved

Manufacturer: Perrigo New York, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 12252 bottles

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Locate your 120 mL bottle of Ciclopirox shampoo 1% and check the label for lot numbers 7DT0280 or 7ET0565 with an expiration date of 02/19.

If your bottle matches these lot numbers and expiration date, stop using the product immediately.

Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse effects.

Return any unused product to your pharmacy to request a refund and contact Perrigo New York, Inc. for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.