Medications & Supplements/Topical Products

Milbar Laboratories, Inc.: Sunscreen and Acne Cleansers Recalled for Microbial Contamination and GMP Issues

Agency Publication Date: May 15, 2018

Summary

Approximately 24,939 units of various skincare products, including B Prox 10 Anti-blemish Wash, Solar Defense Sheer Sunscreen, Naturmetic SPF 50 Sunscreen, and MD Complete Clarifying Cleanser, are being recalled. These products were found to have potential microbial contamination or significant manufacturing quality issues (Good Manufacturing Practice deviations). Consumers should stop using the affected products immediately and contact their healthcare provider or pharmacist.

Risk

The products may contain harmful microbes or were manufactured under conditions that do not meet safety standards, which can lead to skin infections or adverse reactions, especially for users with compromised immune systems or broken skin.

What You Should Do

Check your product packaging for the following identifying information: B Prox 10 Anti-blemish Wash (200 mL bottles), Solar Defense Sheer Sunscreen (2.5 FL OZ tubes), Naturmetic SPF 50 Sunscreen (2.0 fl oz bottles), or MD Complete Clarifying Cleanser (3 fl oz tubes).
Verify if your product matches these specific lot numbers: ET507-0 (Exp. 5/27/2019), GU894-8 (Exp. 7/20/2010), KU455-2 (Exp. 11/09/2020), KU455-6 (Exp. 11/26/2020), KU455-4 (Exp. 10/30/2020), KU503-6, or KU393-6 (Exp. 12/28/2020).
Immediately stop using any of the affected products identified by the lot numbers and expiration dates listed above.
Contact your healthcare provider or pharmacist for guidance if you have experienced any adverse health effects after using these products.
Return any unused product to the place of purchase for a refund and contact Milbar Laboratories, Inc. for further instructions.
For additional questions, contact 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

Contact healthcare provider and return product for refund.

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

Affected Products

Product: B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%) (200 mL)

Lot Numbers:

ET507-0 (Exp. 5/27/2019)

GU894-8 (Exp. 7/20/2010)

Product: Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (74 mL)

Lot Numbers:

KU455-2 (Exp. 11/09/2020)

KU455-6 (Exp. 11/26/2020)

Product: Naturmetic SPF 50 Sunscreen (60 mL)

Lot Numbers:

KU455-4 (Exp. 10/30/2020)

Product: MD Complete Clarifying Cleanser (Salicylic Acid 2.0%) (88.7 mL)

Lot Numbers:

KU503-6 (Exp. 12/28/2020)

KU393-6 (Exp. 12/28/2020)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80042

Status: Resolved

Manufacturer: Milbar Laboratories, Inc.

Sold By: Dermatologic Cosmetic Laboratories; BeautyRx LLC; Fortis BioPharma; MD Professional LLC

Manufactured In: United States

Units Affected: 4 products (3,477 plastic bottles; 2,156 tubes; 4,815 tubes; 14,491 tubes)

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

Check your product packaging for the following identifying information: B Prox 10 Anti-blemish Wash (200 mL bottles), Solar Defense Sheer Sunscreen (2.5 FL OZ tubes), Naturmetic SPF 50 Sunscreen (2.0 fl oz bottles), or MD Complete Clarifying Cleanser (3 fl oz tubes).

Verify if your product matches these specific lot numbers: ET507-0 (Exp. 5/27/2019), GU894-8 (Exp. 7/20/2010), KU455-2 (Exp. 11/09/2020), KU455-6 (Exp. 11/26/2020), KU455-4 (Exp. 10/30/2020), KU503-6, or KU393-6 (Exp. 12/28/2020).

Immediately stop using any of the affected products identified by the lot numbers and expiration dates listed above.

Contact your healthcare provider or pharmacist for guidance if you have experienced any adverse health effects after using these products.

Return any unused product to the place of purchase for a refund and contact Milbar Laboratories, Inc. for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%) (200 mL)

Lot Numbers:

ET507-0 (Exp. 5/27/2019)

GU894-8 (Exp. 7/20/2010)

Product: Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (74 mL)

Lot Numbers:

KU455-2 (Exp. 11/09/2020)

KU455-6 (Exp. 11/26/2020)

Product: Naturmetic SPF 50 Sunscreen (60 mL)

Lot Numbers:

KU455-4 (Exp. 10/30/2020)

Product: MD Complete Clarifying Cleanser (Salicylic Acid 2.0%) (88.7 mL)

Lot Numbers:

KU503-6 (Exp. 12/28/2020)

KU393-6 (Exp. 12/28/2020)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80042

Status: Resolved

Manufacturer: Milbar Laboratories, Inc.

Sold By: Dermatologic Cosmetic Laboratories; BeautyRx LLC; Fortis BioPharma; MD Professional LLC

Manufactured In: United States

Units Affected: 4 products (3,477 plastic bottles; 2,156 tubes; 4,815 tubes; 14,491 tubes)

Distributed To: Nationwide