Medications & Supplements/Topical Products

Akorn Inc: Clobetasol Propionate Emollient Cream Recalled for Failed Stability

Agency Publication Date: February 15, 2019

Summary

Akorn Inc. has voluntarily recalled 9,960 tubes of Clobetasol Propionate Emollient Cream 0.05% because a preservative in the medication failed to meet stability standards during testing. This recall affects both the 30-gram and 60-gram tubes which were distributed nationwide, including Puerto Rico. The issue was discovered during a nine-month stability study that showed "out of specification" results for a preservative intended to maintain the drug's quality. Consumers should check their medicine cabinets for this prescription cream and contact their healthcare provider or pharmacist.

Risk

The failure of the preservative at the nine-month mark means the medication may not maintain its intended quality or effectiveness over time. While the risk is considered low, a compromised preservative system could potentially allow for changes in the product's formulation before its expiration date.

What You Should Do

Identify your product by checking the tube for the name Clobetasol Propionate Emollient Cream 0.05% and the manufacturer Akorn Inc.
Check for the following specific lot numbers and expiration dates: For 30-gram tubes (NDC 50383-270-30), look for lot 357052 with expiration date 4/19/19.
For 60-gram tubes (NDC 50383-270-60), check for lot 356892 with expiration date 4/16/19, and lot 356927 with expiration date 4/15/19.
If your product matches these identifiers, contact your healthcare provider or pharmacist for guidance on continuing your treatment.
Return any unused portions of the affected medication to the pharmacy where it was purchased for a refund.
Contact Akorn Inc. at their corporate location in Lake Forest, Illinois, for further instructions regarding this recall.
For additional questions, call 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

Healthcare consultation and pharmacy refund

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

Affected Products

Product: Clobetasol Propionate Emollient Cream 0.05% (30 gram)

Model:

NDC 50383-270-30

Lot Numbers:

357052 (Exp 4/19/19)

Date Ranges: Expiration 4/19/19

Product: Clobetasol Propionate Emollient Cream 0.05% (60 gram)

Model:

NDC 50383-270-60

Lot Numbers:

356892 (Exp 4/16/19)

356927 (Exp 4/15/19)

Date Ranges: Expiration 4/16/19, Expiration 4/15/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82092

Status: Resolved

Manufacturer: Akorn Inc

Sold By: pharmacies nationwide

Manufactured In: United States

Units Affected: a) 4896 tubes; b) 5064 tubes

Distributed To: Nationwide

Agency Last Updated: February 20, 2019

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

Risk

What You Should Do

Identify your product by checking the tube for the name Clobetasol Propionate Emollient Cream 0.05% and the manufacturer Akorn Inc.

Check for the following specific lot numbers and expiration dates: For 30-gram tubes (NDC 50383-270-30), look for lot 357052 with expiration date 4/19/19.

For 60-gram tubes (NDC 50383-270-60), check for lot 356892 with expiration date 4/16/19, and lot 356927 with expiration date 4/15/19.

If your product matches these identifiers, contact your healthcare provider or pharmacist for guidance on continuing your treatment.

Return any unused portions of the affected medication to the pharmacy where it was purchased for a refund.

Contact Akorn Inc. at their corporate location in Lake Forest, Illinois, for further instructions regarding this recall.

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

Affected Products

Product: Clobetasol Propionate Emollient Cream 0.05% (30 gram)

Model:

NDC 50383-270-30

Lot Numbers:

357052 (Exp 4/19/19)

Date Ranges: Expiration 4/19/19

Product: Clobetasol Propionate Emollient Cream 0.05% (60 gram)

Model:

NDC 50383-270-60

Lot Numbers:

356892 (Exp 4/16/19)

356927 (Exp 4/15/19)

Date Ranges: Expiration 4/16/19, Expiration 4/15/19