The Recall Desk
ModerateFDA (Drugs)·D-0513-2021·Announced 2021-06-02

Cardinal Health Recalls Rugby Benzoyl Peroxide Gel Due to Temperature Excursions

Cardinal Health Inc. is recalling 189 tubes of Rugby Benzoyl Peroxide Gel 5% 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, and the source text cites CGMP deviations regarding temperature excursions without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Cardinal Health Inc. is recalling 189 tubes of Rugby Benzoyl Peroxide (Benzoyl Peroxide) Gel USP, 5%, Net Wt 1.5 oz (42.5 g). The product is an over-the-counter acne medication distributed by Rugby Laboratories.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. The affected lots were distributed between February 23, 2021, and March 10, 2021.

The product was distributed in Florida, Georgia, and South Carolina. Consumers should check their supply of this product and stop using it if it matches the recalled description.

The recalled product

Product
RUGBY BENZOYL PEROXIDE (BENZOYL PEROXIDE)
Brand
RUGBY BENZOYL PEROXIDE
Affected units
189

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 →