Medications & Supplements/Topical Products

Akorn, Inc.: Betamethasone Dipropionate Lotion Recalled for Unknown Impurity

Agency Publication Date: September 16, 2021

Summary

Akorn, Inc. is recalling 264 bottles of Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, a prescription topical medication used to treat skin conditions. This recall was initiated because testing detected an unknown impurity that exceeded the product's quality specifications, which may affect the drug's safety and effectiveness. The recall affects both 30 mL and 60 mL bottles distributed nationwide across the United States.

Risk

The presence of an unknown impurity or degradation product means the medication does not meet its approved quality standards, which could potentially cause skin irritation or reduced effectiveness of the treatment.

What You Should Do

Identify your product by checking the bottle size and NDC number: 30 mL bottles (NDC 61748-480-30) or 60 mL bottles (NDC 61748-480-60).
Check the label for lot numbers 372286 or 372289 with an expiration date of 1/31/2022.
Immediately contact your healthcare provider or pharmacist to discuss your treatment and determine if you should continue using the medication.
Return any unused lotion from the affected lots to your pharmacy to receive a refund.
Contact Akorn, Inc. directly for further instructions regarding the return process or if you have questions about the 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

Pharmacy refund and healthcare consultation.

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

Affected Products

Product: Betamethasone Dipropionate Lotion USP (Augmented), 0.05% (30 mL)

Model:

NDC 61748-480-30

Recall #: D-0802-2021

Lot Numbers:

372286 (Exp 1/31/2022)

372289 (Exp 1/31/2022)

Date Ranges: Exp 1/31/2022

Product: Betamethasone Dipropionate Lotion USP (Augmented), 0.05% (60 mL)

Model:

NDC 61748-480-60

Recall #: D-0802-2021

Lot Numbers:

372286 (Exp 1/31/2022)

372289 (Exp 1/31/2022)

Date Ranges: Exp 1/31/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88488

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 264 bottles; 48 bottles lot 372286 and 216 bottles lot 372289

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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

Identify your product by checking the bottle size and NDC number: 30 mL bottles (NDC 61748-480-30) or 60 mL bottles (NDC 61748-480-60).

Check the label for lot numbers 372286 or 372289 with an expiration date of 1/31/2022.

Immediately contact your healthcare provider or pharmacist to discuss your treatment and determine if you should continue using the medication.

Return any unused lotion from the affected lots to your pharmacy to receive a refund.

Contact Akorn, Inc. directly for further instructions regarding the return process or if you have questions about the 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: Betamethasone Dipropionate Lotion USP (Augmented), 0.05% (30 mL)

Model:

NDC 61748-480-30

Recall #: D-0802-2021

Lot Numbers:

372286 (Exp 1/31/2022)

372289 (Exp 1/31/2022)

Date Ranges: Exp 1/31/2022

Product: Betamethasone Dipropionate Lotion USP (Augmented), 0.05% (60 mL)

Model:

NDC 61748-480-60

Recall #: D-0802-2021

Lot Numbers:

372286 (Exp 1/31/2022)

372289 (Exp 1/31/2022)

Date Ranges: Exp 1/31/2022