Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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
Why it was recalled
Lack of Assurance of Sterility
The recall was initiated by Fresenius Medical Care Holdings, Inc. (the firm that distributes or relabels it); the product is made by Fresenius Medical Care Renal Therapies Group, LLC. That is normal — the distributor, not always the maker, files the recall.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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, 25AU06022, 25AU06027, 25AU06028, 25AU06029, 25AU06030, 25AU06031 25AU06032, 25AU06034, 25AU06035, 25AU06036, 25AU06037, 25AU06038, 25AU06039 25AU06040, 25AU06041, 25AU06042, 25AU06043, 25AU06044, 25AU06045, 25AU06046 25AU06047, 25AU06048, 25AU06049, 25AU06050, 25AU06051, 25AU06052, 25AU06053 & 25AU06056, Exp Date 1/31/26 25BU06001, 25BU06003, 25BU06004, 25BU06005, 25BU06006, 25BU06007, 25BU06008 25BU06009, 25BU06010, 25BU06011, 25BU06018, 25BU06020, 25BU06023, 25BU06024 25BU06026, 25BU06027, 25BU06028, 25BU06030, 25BU06031, 25BU06032, 25BU06033 25BU06034, 25BU06035, 25BU06036, 25BU06037, 25BU06038, 25BU06039, 25BU06040 25BU06041, 25BU06042, 25BU06043, 25BU06044, 25BU06045, 25BU06046 25BU06047, 25BU06049, 25BU06050, 25BU06051, 25BU06053 & 25BU06054, Exp Date 02/28/26 25CU06002, 25CU06003, 25CU06004, 25CU06005, 25CU06006, 25CU06007, 25CU06008 25CU06012, 25CU06013, 25CU06015, 25CU06016, 25CU06020, 25CU06021, 25CU06022 25CU06023, 25CU06024, 25CU06026, 25CU06028, 25CU06030, 25CU06032, 25CU06035 25CU06039, Exp Date 03/31/2026
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Nationwide.
Recall record
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Brand name
- SODIUM CHLORIDE
- Generic name
- SODIUM CHLORIDE
- Product type
- Drugs
- Recall number
- D-0490-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Waltham, MA
- Recall initiated
- 2025-05-27
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall D-0490-2025 · Source: openFDA enforcement.