The Recall Desk
ModerateFDA (Drugs)·D-0402-2021·Announced 2021-06-02

Cardinal Health Recalls Creon Pancrelipase Capsules Due to Temperature Excursions

Cardinal Health Inc. is recalling 1,669 bottles of Creon (pancrelipase) capsules 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 due to CGMP deviations (temperature excursions) without reported illnesses or injuries, fitting the criteria for moderate severity involving potential but unconfirmed risk.

Plain-English summary

Cardinal Health Inc. is recalling 1,669 bottles of Creon (pancrelipase) Delayed-Release Capsules. The product is marketed by AbbVie Inc. and is available in Lipase 36,000 USP Units. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected product was distributed in Florida, Georgia, and South Carolina. The specific code information for the recalled items is 1139494. The recall number is D-0402-2021.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment. The FDA classifies this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
CREON (PANCRELIPASE)
Brand
CREON
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
1,669

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)

  • 1139494

UPCs (8)

  • 0300322637701
  • 0300320045706
  • 0300320047700
  • 0300320046703
  • 0300323016130
  • 0300322636704
  • 0300321212077
  • 0300321224018

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

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Same hazard · temperature excursion

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