CLASS II Drug recall · Reported 17 Jan 2018 · FDA Enforcement Report
Viokace (pancrelipase) tablets, 20,880 USP units recalled by Allergan
Allergan is recalling Viokace (pancrelipase) tablets, 20,880 USP units, distributed nationwide in the US. The recall was initiated on 4 Dec 2017 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-0154-2018
- FDA event ID
- 78652
- Recalling firm
- Allergan, Madison, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Dec 2017
- FDA classified
- 5 Jan 2018
- Reported
- 17 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 4 Dec 2017 | Recall initiated by company | |
| 5 Jan 2018 | Classified by FDA | +32 days |
| 17 Jan 2018 | 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
Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10
Where it was distributed
U.S.A. nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
Which lots are affected?
Lot #: 160741A, Exp 02/18
Where was it sold?
U.S.A. 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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