PANCREAZE — Class III drug recall D-0896-2023
Ongoing recall by Vivus, Inc., reported 2023-07-19, distributed nationwide. Failed Stability Specifications
| Recall number | D-0896-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vivus, Inc., Campbell, CA, United States |
| Recall initiated | 2023-06-23 |
| Classified | 2023-07-07 |
| Reported by FDA | 2023-07-19 |
| Distributed | Nationwide (US) |
| Quantity | 4,240 bottles |
| Reason classes | specification failure |
| NDC | 62541-0401, 62541-0401-10, 62541-0402, 62541-0402-10, 62541-0403, 62541-0403-10, 62541-0404, 62541-0404-10, 62541-0405, 62541-0405-10, 62541-0406, 62541-0406-10, 62541-0406-50 |
| Lot numbers | 102101 |
| Expiration dates | 2024-07-31 |
Product
PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10,
Reason for recall
Failed Stability Specifications
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-0896-2023. 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.