Medications & Supplements/Topical Products

Lupin Clobetasol Propionate Cream Recalled for Being Subpotent

Agency Publication Date: January 23, 2023

Summary

Lupin Pharmaceuticals Inc. is recalling 5,720 tubes of Clobetasol Propionate Cream USP (0.05%), a prescription topical medication. Long-term stability testing revealed the cream is subpotent, meaning it contains lower levels of the active ingredient than required. This recall affects 45 g tubes with NDC 68180-956-03 and lot number K101033.

Risk

A subpotent medication may not effectively treat the skin conditions for which it was prescribed. No injuries or adverse incidents related to this recall have been reported.

What You Should Do

This recall affects Clobetasol Propionate Cream USP (0.05%) in 45 g tubes manufactured for Lupin Pharmaceuticals, Inc. (NDC 68180-956-03).
Check the product packaging for lot number K101033 with an expiration date of June 2024 (6/2024).
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 Lupin Pharmaceuticals Inc. 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 Cream USP, 0.05% (45 g tube)by Lupin Pharmaceuticals, Inc.

Variants: 0.05%, 45 g tube

Lot Numbers:

K101033 (Exp 6/2024)

NDC:

68180-956-03

Manufactured by Lupin Limited in India and distributed by Lupin Pharmaceuticals in the United States.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91532

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: pharmacies; hospitals

Manufactured In: India, United States

Units Affected: 5720 tubes

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

This recall affects Clobetasol Propionate Cream USP (0.05%) in 45 g tubes manufactured for Lupin Pharmaceuticals, Inc. (NDC 68180-956-03).

Check the product packaging for lot number K101033 with an expiration date of June 2024 (6/2024).

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 Lupin Pharmaceuticals Inc. for further instructions.

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