The Recall Desk
ModerateFDA (Drugs)·D-0444-2021·Announced 2021-06-02

Cardinal Health Recalls Benzefoam Emollient Foam Due to Temperature Excursions

Cardinal Health Inc. is recalling Benzefoam Emollient Foam due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

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 and involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling Benzefoam Emollient Foam, an over-the-counter topical product containing 5.3% benzoyl peroxide. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.

The affected product is identified by NDC 187-0194--10. The recall includes all lots distributed between February 23, 2021, and March 10, 2021. The product was distributed in Florida, Georgia, and South Carolina.

Consumers who have this product should stop using it and contact Cardinal Health Inc. for further instructions or a refund.

The recalled product

Product
BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS
Manufacturer
Cardinal Health Inc.
Category
Drug — Topical OTC
Hazard
Affected units
2

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

Distributed in 3 states:

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.

See all 198 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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