Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Pancrelipase recalled?

Yes — there is an active recall. 1 ongoing FDA recall mention Pancrelipase (8 total). Check the affected lots below.

Most common reason: Labeling / mix-up (4 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Pancrelipase. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Pancrelipase recalls on record

none so far in 2026; 8 on record, newest first
Class II · Moderate risk

Creon (pancrelipase)

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 0032-3016-13 D-0402-2021
Class II · Moderate risk

Viokace (pancrelipase)

Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.

Terminated Wrong potency / content Allergan NDC 58914-117-10 D-0154-2018
Class II · Moderate risk

Pancrelipase Dr

Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units may be potentially mislabeled as one of the following drugs: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD70585_7, EXP: 5/29/2014; THYROID, Tablet, 60 mg, NDC 00456045901, Pedigree: W002848, EXP: 6/7/2014; CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: W003744, EXP: 6/26/2014; amLOD

Terminated Labeling / mix-up Aidapak Services, LLC D-785-2014
Class II · Moderate risk

Pancrelipase Dr

Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as the following drug: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, NDC 00597000160, Pedigree: AD70639_4, EXP: 7/28/2013.

Terminated Labeling / mix-up Aidapak Services, LLC D-784-2014
Class II · Moderate risk

Pancrelipase Dr

Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003726, EXP: 6/26/2014; LANTHANUM CARBONATE, CHEW Tablet, 500 mg, NDC 54092025290, Pedigree: W002790, EXP: 6/6/2014; CITALOPRAM, Tablet, 10 mg, NDC 57664050788, Pedigree: W002844, EXP: 6/7/2014; AT

Terminated Labeling / mix-up Aidapak Services, LLC D-783-2014
Class II · Moderate risk

PANCRELIPASE DR Capsule

Labeling: Label Mixup; PANCRELIPASE DR Capsule may be potentially mislabeled as MELATONIN, Tablet, 1 mg, NDC 35046000391, Pedigree: W003317, EXP: 6/18/2014; VERAPAMIL HCL, Tablet, 40 mg, NDC 00591040401, Pedigree: W003170, EXP: 6/13/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-558-2014