The Recall Desk
ModerateFDA (Drugs)·D-0407-2021·Announced 2021-06-02

Cardinal Health Recalls Fenofibrate Capsules Due to Temperature Excursions

Cardinal Health Inc. is recalling 106 boxes of Fenofibrate capsules 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 does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving potential quality deviations.

Plain-English summary

Cardinal Health Inc. is recalling 106 boxes of Fenofibrate capsules, NDC 27241-118-04. The recall was initiated due to CGMP deviations involving intermittent exposure to temperature excursions during storage.

The affected product is a prescription medication distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled product is PA03410.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.

The recalled product

Product
FENOFIBRATE (FENOFIBRATE)
Brand
FENOFIBRATE
Affected units
106

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)

  • PA03410

UPCs (3)

  • 0327241119040
  • 0327241118043
  • 0327241120046

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 →