Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Dist… recall
FDA recall D-0273-2025 · initiated Feb 24, 2025
Denison Pharmaceuticals, LLC recalled Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g)… in Feb 2025 — an FDA Class II recall (D-0273-2025) because Chemical Contamination: Presence of benzene.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Chemical Contamination: Presence of benzene.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 642,131 tubes
Details
- Product
- 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
- Recalling company
- Denison Pharmaceuticals, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the USA
- Initiated
- Feb 24, 2025
- FDA report date
- Mar 19, 2025
Frequently asked
- Was Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g)… recalled?
- Denison Pharmaceuticals, LLC recalled Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g)… in Feb 2025 — an FDA Class II recall (D-0273-2025) because Chemical Contamination: Presence of benzene. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g)… recalled?
- Per the FDA enforcement record, the reason for recall D-0273-2025 was: Chemical Contamination: Presence of benzene.
- Is a recalled Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g)… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g)… are affected?
- Distributed: Nationwide within the USA. The recall covers these lots — 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. D…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0273-2025.