Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36 Recalled by Cardinal Health Inc. Due to CGMP Deviations: Intermittent exposure to temperature excursion during...

Date: March 15, 2021
Company: Cardinal Health Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cardinal Health Inc. directly.

Affected Products

Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A.

Quantity: 1669 bottles

Why Was This Recalled?

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Where Was This Sold?

This product was distributed to 3 states: FL, GA, SC

Affected (3 states)Not affected

About Cardinal Health Inc.

Cardinal Health Inc. has 240 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report