0 — Class II drug recall D-0490-2025
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2025-07-02, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0490-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2025-05-27 |
| Classified | 2025-06-23 |
| Reported by FDA | 2025-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 3,651,468 containers |
| Reason classes | sterility |
| NDC | 49230-0300, 49230-0300-10 |
| Expiration dates | 2025-11-30, 2025-12-31, 2026-01-31, 2026-02-28, 2026-03-31 |
Product
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
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-0490-2025. 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.