Medications & Supplements/Topical Products

Lexette Topical Foam Recalled for Dispensing and Foam Quality Defects

Agency Publication Date: January 19, 2022

Summary

Mayne Pharma Inc has issued a voluntary recall for approximately 17,113 canisters of Lexette (halobetasol propionate) Topical Foam, 0.05%. The product is being recalled due to manufacturing deviations that result in the canister either being difficult to dispense, failing to dispense entirely, or dispensing as a liquid rather than the intended foam. No injuries or adverse events have been reported in connection with this issue.

Risk

The dispensing defect may prevent users from receiving their prescribed dosage or result in the medication being applied in an incorrect physical form, which could impact the effectiveness of the treatment.

What You Should Do

This recall affects Lexette (halobetasol propionate) Topical Foam, 0.05% in 50 g canisters, which is a prescription-only medication identified by NDC 51862-604-50.
Check the lot number and expiration date printed on the canister or packaging to see if your product is affected. The recalled lots include 32451, 32532, 32552, 32701, 32733, 32855, and 32872. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Mayne Pharma Inc for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lexette (halobetasol propionate) Topical Foam, 0.05% (50 g canister)

Variants: Topical Foam, 0.05%, 50 g canisters, Rx ONLY

Model:

D-0387-2022

Lot Numbers:

32451 (Exp. 03/2022)

32532 (Exp. 04/2022)

32552 (Exp. 05/2022)

32701 (Exp. 10/2022)

32733 (Exp. 10/2022)

32855 (Exp. 02/2023)

32872 (Exp. 03/2023)

NDC:

51862-604-50

Distributed by: Mayne Pharma Greenville, NC 27834

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89397

Status: Active

Manufacturer: Mayne Pharma Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 17,113 canisters

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

This recall affects Lexette (halobetasol propionate) Topical Foam, 0.05% in 50 g canisters, which is a prescription-only medication identified by NDC 51862-604-50.

Check the lot number and expiration date printed on the canister or packaging to see if your product is affected. The recalled lots include 32451, 32532, 32552, 32701, 32733, 32855, and 32872. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Mayne Pharma Inc for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lexette (halobetasol propionate) Topical Foam, 0.05% (50 g canister)

Variants: Topical Foam, 0.05%, 50 g canisters, Rx ONLY

Model:

D-0387-2022

Lot Numbers:

32451 (Exp. 03/2022)

32532 (Exp. 04/2022)

32552 (Exp. 05/2022)

32701 (Exp. 10/2022)

32733 (Exp. 10/2022)

32855 (Exp. 02/2023)

32872 (Exp. 03/2023)

NDC:

51862-604-50

Distributed by: Mayne Pharma Greenville, NC 27834