Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEA
Summary
The FDA issued a Class II for Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) by Denison Pharmaceuticals, LLC. Reason: Chemical Contamination: Presence of benzene..
Details
Source
Drug Recall
External ID
D-0273-2025
Action Date
2025-03-19
Status
Ongoing
Category
drug
Product Description
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1
Lot/Code Info: Lot #: 9762, Exp. Date 2/28/2025; 9763, 9764, 9765, Exp. Date 3/31/2025; 9869, 9870, Exp. Date 5/31/2025; 9871, 9872, Exp. Date 7/31/2025; 9996, 9997, 9998, Exp. Date 8/31/2025; 9995, Exp. Date 10/31/2025; 0154, 0153, 0326, Exp. Date 1/31/2026; 0155, 0156, 0161, 0327, 0329, 0328, Exp. Date 2/28/2026; 0479, 0480, Exp. Date 5/31/2026.
Quantity Affected: 642,131 tubes
Reason for Recall
Chemical Contamination: Presence of benzene.
Distribution
Nationwide within the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-24
Company
Lincoln, RI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Denison Pharmaceuticals, LLC has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Denison Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Denison Pharmaceuticals, LLC have FDA actions?
Denison Pharmaceuticals, LLC has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0273-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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