The Recall Desk
ModerateFDA (Drugs)·D-0518-2021·Announced 2021-06-02

Cardinal Health Recalls Rugby Benzoyl Peroxide Wash Due to Temperature Excursions

Cardinal Health is recalling Rugby Benzoyl Peroxide Wash 5% 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 due to CGMP deviations involving temperature excursions. Per the rubric, this falls under moderate severity as it involves a potential quality issue without reported injuries or specific high-risk pathogen contamination.

Plain-English summary

Cardinal Health Inc. is recalling Rugby Benzoyl Peroxide Wash 5% (148 mL) due to current Good Manufacturing Practice (CGMP) deviations. The recall is caused by intermittent exposure to temperature excursions during storage.

The affected product is identified by NDC/UPC 0536-1259-63 and consists of 37 bottles. All lots were 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 FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
RUGBY BENZOYL PEROXIDE WASH (BENZOYL PEROXIDE)
Brand
RUGBY BENZOYL PEROXIDE WASH
Manufacturer
Cardinal Health Inc.
Category
Drug — Topical OTC
Hazard
Affected units
37

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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