0 — Class II drug recall D-0433-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2026-04-15, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0433-2026 |
|---|---|
| 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 | 65219-0282, 65219-0282-01, 65219-0282-10 |
| Lot numbers | 23SU10001, 24AU10003, 24AU10004, 24AU10005, 24AU10008, 24EU10001, 24EU10002, 24PU10002, 25BU10003, 25EU10005 |
| Expiration dates | 2026-12-31, 2027-01-31, 2027-05-31, 2027-11-30, 2028-02-29, 2028-05-31 |
Product
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.
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-0433-2026. 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.