Medications & Supplements/Topical Products

Zapzyt Acne Treatment Gel Recalled for Benzene Contamination

Agency Publication Date: March 12, 2025

Summary

Denison Pharmaceuticals, LLC is recalling 642,131 tubes of Zapzyt Acne Treatment Gel (10% benzoyl peroxide) because of chemical contamination. Testing revealed the presence of benzene, a known human carcinogen, within the product. Consumers should stop using the gel immediately and contact their healthcare provider or pharmacist if they have experienced any health concerns.

Risk

Benzene is classified as a human carcinogen; long-term exposure to benzene through the skin, inhalation, or orally can result in life-threatening blood disorders, such as leukemia and bone marrow cancer.

What You Should Do

This recall affects 1 oz (28.35g) tubes of Zapzyt Acne Treatment Gel (10% benzoyl peroxide) with NDC 71687-0011-1.
Check the lot number and expiration date printed on the tube or the product carton to determine if your product is affected. 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 Denison Pharmaceuticals, LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

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: Zapzyt Acne Treatment Gel (1 oz)

Variants: 10% benzoyl peroxide Gel

Lot Numbers:

9762 (Exp. Date 2/28/2025)

9763 (Exp. Date 3/31/2025)

9764 (Exp. Date 3/31/2025)

9765 (Exp. Date 3/31/2025)

9869 (Exp. Date 5/31/2025)

9870 (Exp. Date 5/31/2025)

9871 (Exp. Date 7/31/2025)

9872 (Exp. Date 7/31/2025)

9996 (Exp. Date 8/31/2025)

9997 (Exp. Date 8/31/2025)

9998 (Exp. Date 8/31/2025)

9995 (Exp. Date 10/31/2025)

0154 (Exp. Date 1/31/2026)

0153 (Exp. Date 1/31/2026)

0326 (Exp. Date 1/31/2026)

0155 (Exp. Date 2/28/2026)

0156 (Exp. Date 2/28/2026)

0161 (Exp. Date 2/28/2026)

0327 (Exp. Date 2/28/2026)

0329 (Exp. Date 2/28/2026)

0328 (Exp. Date 2/28/2026)

0479 (Exp. Date 5/31/2026)

0480 (Exp. Date 5/31/2026)

NDC:

71687-0011-1

Distributed by Focus Consumer Healthcare, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96384

Status: Active

Manufacturer: Denison Pharmaceuticals, LLC

Sold By: retail stores; pharmacies; online retailers

Manufactured In: United States

Units Affected: 642,131 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

This recall affects 1 oz (28.35g) tubes of Zapzyt Acne Treatment Gel (10% benzoyl peroxide) with NDC 71687-0011-1.

Check the lot number and expiration date printed on the tube or the product carton to determine if your product is affected. 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 Denison Pharmaceuticals, LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

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: Zapzyt Acne Treatment Gel (1 oz)

Variants: 10% benzoyl peroxide Gel

Lot Numbers:

9762 (Exp. Date 2/28/2025)

9763 (Exp. Date 3/31/2025)

9764 (Exp. Date 3/31/2025)

9765 (Exp. Date 3/31/2025)

9869 (Exp. Date 5/31/2025)

9870 (Exp. Date 5/31/2025)

9871 (Exp. Date 7/31/2025)

9872 (Exp. Date 7/31/2025)

9996 (Exp. Date 8/31/2025)

9997 (Exp. Date 8/31/2025)

9998 (Exp. Date 8/31/2025)

9995 (Exp. Date 10/31/2025)

0154 (Exp. Date 1/31/2026)

0153 (Exp. Date 1/31/2026)

0326 (Exp. Date 1/31/2026)

0155 (Exp. Date 2/28/2026)

0156 (Exp. Date 2/28/2026)

0161 (Exp. Date 2/28/2026)

0327 (Exp. Date 2/28/2026)

0329 (Exp. Date 2/28/2026)

0328 (Exp. Date 2/28/2026)

0479 (Exp. Date 5/31/2026)

0480 (Exp. Date 5/31/2026)

NDC:

71687-0011-1

Distributed by Focus Consumer Healthcare, LLC.