CLASS II ONGOING Drug recall · Reported 19 Mar 2025 · FDA Enforcement Report
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel recalled
Denison Pharmaceuticals is recalling Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, distributed nationwide in the US. The recall was initiated on 24 Feb 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0273-2025
- FDA event ID
- 96384
- Recalling firm
- Denison Pharmaceuticals, Lincoln, RI
- Manufacturer
- Focus Consumer Healthcare, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Feb 2025
- FDA classified
- 12 Mar 2025
- Reported
- 19 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Benzene
- Drug class
- Creams, Ointments & Gels
Timeline
| 24 Feb 2025 | Recall initiated by company | |
| 12 Mar 2025 | Classified by FDA | +16 days |
| 19 Mar 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical Contamination: Presence of benzene.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the USA
Questions about this recall
Is Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel recalled?
Yes. Denison Pharmaceuticals recalled Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel on 24 Feb 2025. The recall is Class II and its status is Ongoing. Recall number D-0273-2025.
Why was it recalled?
Chemical Contamination: Presence of benzene.
Which lots are affected?
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.
Where was it sold?
Nationwide within the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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Other Benzoyl Peroxide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acne Medication Benzoyl Peroxide Gel recalled by Cardinal HealthRugby Benzoyl Peroxide | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Benzoyl Peroxide 5% Aqueous Base, Acne Treatment Gel recalledBenzoyl Peroxide | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |