Medications & Supplements/Topical Products

Westminster Pharmaceuticals Hydroquinone Cream Recalled for Quality Failure

Agency Publication Date: September 27, 2021

Summary

Monarch PCM, LLC is recalling 11,419 tubes of Hydroquinone USP, 4% Skin Bleaching Cream (generic name: hydroquinone) because the product failed to meet official quality standards. This prescription-only medication, sold under the Westminster Pharmaceuticals brand in 1-ounce tubes, did not meet required USP specifications. No incidents or injuries have been reported to date.

Risk

A quality specification failure means the medication may not have the correct strength or purity required for safe and effective use. This could result in the product being less effective or causing unintended skin irritation.

What You Should Do

This recall affects Westminster Pharmaceuticals Hydroquinone USP, 4% Skin Bleaching Cream sold in 1 oz (28.35g) tubes with NDC code 69367-174-01.
Identify affected products by checking for lot numbers 21FP1743 or 21FP1745, both with an expiration date of May 2023 (05/2023).
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 Westminster 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: Hydroquinone USP, 4% Skin Bleaching Cream (1 oz)

Variants: 4% Strength, 1 oz (28.35g) Tube, Rx only

Lot Numbers:

21FP1743 (Exp 05/2023)

21FP1745 (Exp 05/2023)

NDC:

69367-174-01

Recall #: D-0855-2021; Manufactured for Westminster Pharmaceuticals, LLC Nashville, TN 37217

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88755

Status: Resolved

Manufacturer: Monarch PCM, LLC

Sold By: Westminster Pharmaceuticals, LLC

Manufactured In: United States

Units Affected: 11,419 tubes

Distributed To: Tennessee

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 Westminster Pharmaceuticals Hydroquinone USP, 4% Skin Bleaching Cream sold in 1 oz (28.35g) tubes with NDC code 69367-174-01.

Identify affected products by checking for lot numbers 21FP1743 or 21FP1745, both with an expiration date of May 2023 (05/2023).

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 Westminster Pharmaceuticals, LLC for further instructions.

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