FDA Drug recall D-0213-2025
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by:…
- FDA Drug
- Class II
- ongoing
- Published 2025-02-05
On 2025-02-05 the FDA classified a Class II recall of Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by:… by Mckesson, citing cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0213-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-17 |
| Published | 2025-02-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mckesson |
| Distribution | US |
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
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Identifiers
| ndc | 0069-0809-01 |
|---|---|
| code_info | Lot# 04647349, Exp Date 5/31/2029 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0213-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.