Viokace — Class II drug recall D-0154-2018
Terminated recall by ALLERGAN, reported 2018-01-17, distributed nationwide. Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the
| Recall number | D-0154-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ALLERGAN, Madison, NJ, United States |
| Recall initiated | 2017-12-04 |
| Classified | 2018-01-05 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2019-06-20 |
| Distributed | Nationwide (US) |
| Quantity | 12,699 bottles |
| Reason classes | potency, specification failure |
| NDC | 58914-0117-10 |
| Lot numbers | 02/18, 160741A |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0154-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.