Creon — Class II drug recall D-0402-2021
Terminated recall by Cardinal Health Inc., reported 2021-06-02, distributed in FL, GA, SC. CGMP Deviations: Intermittent exposure to temperature excursion during storage.
| Recall number | D-0402-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health Inc., Dublin, OH, United States |
| Recall initiated | 2021-03-15 |
| Classified | 2021-05-24 |
| Reported by FDA | 2021-06-02 |
| Terminated | 2024-06-17 |
| Distributed | FL, GA, SC |
| Quantity | 1,669 bottles |
| Reason classes | cgmp, temperature control |
| NDC | 00032-0045, 00032-0045-30, 00032-0045-70, 00032-0046, 00032-0046-30, 00032-0046-70, 00032-0047, 00032-0047-30, 00032-0047-70, 00032-1203, 00032-1203-64, 00032-1203-70, 00032-1206, 00032-1206-01, 00032-1206-07, 00032-1206-56, 00032-1212, 00032-1212-01, 00032-1212-07, 00032-1212-13, 00032-1212-46, 00032-1224, 00032-1224-01, 00032-1224-07, 00032-1224-46 and 13 more |
Product
Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A.
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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-0402-2021. 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.