0 — Class II drug recall D-0427-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2026-04-15, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0427-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2026-03-11 |
| Classified | 2026-04-03 |
| Reported by FDA | 2026-04-15 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 65219-0466, 65219-0466-05, 65219-0466-60, 65219-0468, 65219-0468-05, 65219-0468-50, 65219-0470, 65219-0470-05, 65219-0470-30, 65219-0472, 65219-0472-05, 65219-0472-20, 65219-0474, 65219-0474-05, 65219-0474-10 |
| Lot numbers | 23SU10008, 24JU10003, 24LU10011, 24LU10012, 6402273, 6402275, 6402420, 6402421, 6402422, 6402423, 6402473, 6402474, 6402475, 6402476, 6402485, 6402516 |
| Expiration dates | 2026-12-31, 2027-07-31, 2027-09-30, 2028-01-31, 2028-03-31, 2028-04-30, 2028-05-31 |
Product
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.
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-0427-2026. 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.