Class III · Low risk
Kids' Cough and Chest Congestion
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Zapzyt (Benzoyl Peroxide)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Chemical Contamination: Presence of benzene.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
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
Affected NDC
71687-0011-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Zapzyt Acne Treatment Gel Benzoyl Peroxide NDC 71687-0011 |
10 g/100g | Gel Topical |
Focus Consumer Healthcare, LLC | OTC |
- Recalling firm
- Denison Pharmaceuticals, LLC
- NDC code
- 71687-0011-1
- Origin
- RI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0273-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Denison Pharmaceuticals, LLC
All 2025 recalls
Class III · Low risk
Adult Cough and Chest Congestion
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class II · Moderate risk
Little Remedies Gas Relief Drops
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Class II · Moderate risk
Safe tussin PM
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Other chemical / undeclared recalls from 2025
All chemical / undeclared recalls
Class I · High risk
MR. 7 SUPER 700000 capsules
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Class II · Moderate risk
Agebox iKids-Growth
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Class II · Moderate risk
Agebox iKids-Growth
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Class I · High risk
SILINTAN 25/pills
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
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