Pancrelipase recalls

The FDA has published 6 recalls involving Pancrelipase since 2014. The latest was reported on 2 Jun 2021. Most were for labeling errors. Aidapak Services has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls6since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 2 Jun 2021

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why pancrelipase is recalled

Companies

By year

2021117%
2014583%

All pancrelipase recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
2 Jun 2021Drug	CLASS II	Creon (pancrelipase) Delayed-Release Capsules Dose recalledCreon	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
8 Oct 2014Drug	CLASS II	Creon (pancrelipase) Delayed-Release Capsules recalled by AbbVieCreon	AbbVie	Other	Nationwide
29 Jan 2014Drug	CLASS II	Pancrelipase DR, Capsule, 12000 /38000 /60000 USP units recalled	Aidapak Services	Labeling Errors	4 states
29 Jan 2014Drug	CLASS II	Pancrelipase DR, Capsule, 12000 /38000 /60000 USP units recalled	Aidapak Services	Labeling Errors	4 states
29 Jan 2014Drug	CLASS II	Pancrelipase DR, Capsule, 24000 /76000 /120000 USP units recalled	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Pancrelipase DR Capsule recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Pancrelipase?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.