FDA Drug recall D-0490-2025
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323…
- FDA Drug
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323… by Fresenius Medical Care Holdings, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0490-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-27 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
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
Lack of Assurance of Sterility
Identifiers
| ndc | 49230-300-10 |
|---|---|
| code_info | 24PU06037, 24PU06038, 24PU06040, 24PU06041, 24PU06042, 24PU06043, 24PU06044, 24PU06045, 24PU0646, 24PU06047, 24PU06048,…24PU06037, 24PU06038, 24PU06040, 24PU06041, 24PU06042, 24PU06043, 24PU06044, 24PU06045, 24PU0646, 24PU06047, 24PU06048, 24PU06049, 24PU06050, 24PU06052, 24PU06053, 24PU06054 & 24PU06055, Exp Date 11/30/2025; 24SU06001, 24SU06002, 24SU06003, 24SU06004, 24SU06005, 24SU06006, 24SU06007, 24SU06009, 24SU06010, 24SU06011 24SU06012, 24SU06013, 24SU06014, 24SU06015, 24SU06016, 24SU06017, 24SU06018, 24SU06019, 24SU06020, 24SU06021, 24SU06022, 24SU06023, 24SU06024, 24SU06025,24SU06026, 24SU06028,24SU06029, 24SU06030, 24SU06031, 24SU06032, 24SU06033 24SU06034, 24SU06035, 24SU06036, 24SU06037, 24SU06038, 24SU06039, 24SU06040, 24SU06041, 24SU06042, 24SU06043, 24SU06044, 24SU06045, 24SU06046, 24SU06047, 24SU06048, 24SU06049, 24SU06050, 24SU06051, 24SU06052, 24SU06053, 24SU06054, 24SU06055, 24SU06056, & 24SU06057, Exp Date 12/31/25 25AU06001, 25AU06002, 25AU06003. 25AU06004, 25AU06005, 25AU06006, 25AU06007, 25AU06008, 25AU06009, 25AU06010, 25AU06011, 25AU06013, 25AU06017, 25AU06020 25AU06021, 25A |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0490-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.