Inflectra — Class II drug recall D-0213-2025
Ongoing recall by McKesson, reported 2025-02-05, distributed nationwide. cGMP Deviations: Product intended for quarantine was inadvertently distributed.
| Recall number | D-0213-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | McKesson, Irving, TX, United States |
| Recall initiated | 2025-01-17 |
| Classified | 2025-01-30 |
| Reported by FDA | 2025-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 192 vials |
| Reason classes | cgmp |
| NDC | 00069-0809, 00069-0809-01 |
| Lot numbers | 04647349 |
| Expiration dates | 2029-05-31 |
Product
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01
Reason for recall
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
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-0213-2025. 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.