0 — Class II drug recall D-0432-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2026-04-15, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0432-2026 |
|---|---|
| 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 | 65219-0328, 65219-0328-10, 65219-0328-50, 65219-0432, 65219-0432-20, 65219-0432-85 |
| Lot numbers | 23DU10004, 23HU10006 |
| Expiration dates | 2026-04-30, 2026-06-30 |
Product
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.
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-0432-2026. 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.