IMULDOSA — Class II drug recall D-0653-2026
Ongoing recall by ACCORD BIOPHARMA INC, reported 2026-07-08, distributed nationwide. Lack of assurance of Sterility:
| Recall number | D-0653-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ACCORD BIOPHARMA INC, Raleigh, NC, United States |
| Recall initiated | 2026-06-10 |
| Classified | 2026-06-29 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 326 vials |
| Reason classes | sterility |
| NDC | 69448-0017, 69448-0017-63, 69448-0018, 69448-0018-63, 69448-0019, 69448-0019-26 |
| Lot numbers | 004L24A |
| Expiration dates | 2027-02-19 |
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 for recall
Lack of assurance of Sterility:
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-0653-2026. 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.