FDA Drug recall D-0653-2026
IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco…
- FDA Drug
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco… by Accord Biopharma, citing lack of assurance of Sterility:.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0653-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-10 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Biopharma |
| Distribution | US |
Product
IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.
Reason
Lack of assurance of Sterility:
Identifiers
| ndc | 69448-018-63 |
|---|---|
| ndc | 69448-017-63 |
| ndc | 69448-019-26 |
| code_info | Lot # 004L24A, Exp Date: 02/19/2027. |
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-0653-2026%22
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