Cardinal Health Recalls Benzoyl Peroxide Gel Due to Temperature Excursions
Cardinal Health is recalling Benzoyl Peroxide 2.5% Acne Treatment Gel due to intermittent temperature excursions during storage.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a manufacturing deviation (temperature excursion) without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 5 tubes of Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel (NDC 45802-101-96). The product is distributed by Perrigo in Allegan, MI, and was distributed in Florida, Georgia, and South Carolina. All lots distributed between February 23, 2021, and March 10, 2021, are affected.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. This condition may affect the stability or quality of the topical medication.
Consumers who have purchased this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- BENZOYL PEROXIDE (BENZOYL PEROXIDE)
- Brand
- BENZOYL PEROXIDE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Topical OTC
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots distributed 02/23/2021 through 03/10/2021.
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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