Medications & Supplements/Topical Products

Ingenus Clobetasol Propionate Foam Recalled for Manufacturing Violations

Agency Publication Date: January 14, 2022

Summary

Ingenus Pharmaceuticals LLC is recalling 45,173 cans of Clobetasol Propionate Foam (0.05%), a prescription medication used to treat various skin conditions. This recall was initiated due to deviations from Current Good Manufacturing Practice (CGMP) requirements, which are the federal standards that ensure pharmaceutical quality and safety. No injuries or incidents have been reported in relation to this manufacturing issue.

Risk

Failure to follow mandatory manufacturing standards can result in medication that does not meet quality specifications for potency or purity, potentially affecting the drug's safety or how well it works. No reports of adverse health effects have been received.

What You Should Do

The recalled products are Ingenus Clobetasol Propionate Foam, 0.05%, sold in 50g cans (NDC 50742-304-50) and 100g cans (NDC 50742-304-01).
For the 50g cans, check the packaging for lot numbers 32921 (Exp. 06/2022), 33152 (Exp. 08/2022), or 33340 (Exp. 11/2022).
For the 100g cans, check the packaging for lot numbers 33152 (Exp. 08/2022) or 33340 (Exp. 11/2022).
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 Ingenus Pharmaceuticals LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Clobetasol Propionate Foam, 0.05% (50g)

Variants: 50 g can

Lot Numbers:

32921 (Exp. 06/2022)

33152 (Exp. 08/2022)

33340 (Exp. 11/2022)

NDC:

50742-304-50

Rx only; Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL.

Product: Clobetasol Propionate Foam, 0.05% (100g)

Variants: 100 g can

Lot Numbers:

33152 (Exp. 08/2022)

33340 (Exp. 11/2022)

NDC:

50742-304-01

Rx only; Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89393

Status: Resolved

Manufacturer: Ingenus Pharmaceuticals Llc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 45,173 cans

Distributed To: Nationwide

Agency Last Updated: January 28, 2022

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

The recalled products are Ingenus Clobetasol Propionate Foam, 0.05%, sold in 50g cans (NDC 50742-304-50) and 100g cans (NDC 50742-304-01).

For the 50g cans, check the packaging for lot numbers 32921 (Exp. 06/2022), 33152 (Exp. 08/2022), or 33340 (Exp. 11/2022).

For the 100g cans, check the packaging for lot numbers 33152 (Exp. 08/2022) or 33340 (Exp. 11/2022).

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 Ingenus Pharmaceuticals LLC for further instructions.

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

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: Clobetasol Propionate Foam, 0.05% (50g)

Variants: 50 g can

Lot Numbers:

32921 (Exp. 06/2022)

33152 (Exp. 08/2022)

33340 (Exp. 11/2022)

NDC:

50742-304-50

Rx only; Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL.

Product: Clobetasol Propionate Foam, 0.05% (100g)

Variants: 100 g can

Lot Numbers:

33152 (Exp. 08/2022)

33340 (Exp. 11/2022)

NDC:

50742-304-01

Rx only; Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL.