CLASS II Drug recall · Reported 8 Oct 2014 · FDA Enforcement Report
Creon (pancrelipase) Delayed-Release Capsules recalled by AbbVie
AbbVie is recalling Creon (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, distributed nationwide in the US. The recall was initiated on 15 Sep 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1611-2014
- FDA event ID
- 69285
- Recalling firm
- AbbVie, North Chicago, IL
- Brand
- Creon
- Manufacturer
- AbbVie Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Sep 2014
- FDA classified
- 26 Sep 2014
- Reported
- 8 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 15 Sep 2014 | Recall initiated by company | |
| 26 Sep 2014 | Classified by FDA | +11 days |
| 8 Oct 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Product as listed by the FDA
CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07.
Where it was distributed
US: Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Which lots are affected?
Lot #: 1020156; Expiry: 3/31/2016
Where was it sold?
US: Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Pancrelipase recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Creon (pancrelipase) Delayed-Release Capsules Dose recalledCreon | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Pancrelipase DR, Capsule, 12000 /38000 /60000 USP units recalled | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Pancrelipase DR, Capsule, 12000 /38000 /60000 USP units recalled | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Pancrelipase DR, Capsule, 24000 /76000 /120000 USP units recalled | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Pancrelipase DR Capsule recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |