The Recall Desk
ModerateFDA (Drugs)·D-0549-2021·Announced 2021-06-02

Cardinal Health Recalls Podofilox Topical Solution Due to Temperature Excursions

Cardinal Health Inc. is recalling 180 bottles of Podofilox Topical Solution 0.5% due to intermittent exposure to 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 does not report any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Cardinal Health Inc. is recalling 180 bottles of Podofilox Topical Solution 0.5%, 3.5 mL, prescription only. The product is manufactured by Perrigo in Minneapolis, MN, and carries the NDC 0574-0611-05. The specific lot code is 402995.

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 medication.

The affected product was distributed in Florida, Georgia, and South Carolina. Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
PODOFILOX (PODOFILOX)
Brand
PODOFILOX
Affected units
180

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)

  • 402995

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 →