0.45% Sodium Chloride Injection recall
FDA recall D-0424-2026 · initiated Mar 11, 2026
Fresenius Kabi USA, LLC recalled 0.45% Sodium Chloride Injection in Mar 2026 — an FDA Class II recall (D-0424-2026) because Lack of Assurance of Sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- Product
- 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).
- Recalling company
- Fresenius Kabi USA LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Initiated
- Mar 11, 2026
- FDA report date
- Apr 15, 2026
Frequently asked
- Was 0.45% Sodium Chloride Injection recalled?
- Fresenius Kabi USA, LLC recalled 0.45% Sodium Chloride Injection in Mar 2026 — an FDA Class II recall (D-0424-2026) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was 0.45% Sodium Chloride Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0424-2026 was: Lack of Assurance of Sterility
- Is a recalled 0.45% Sodium Chloride Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of 0.45% Sodium Chloride Injection are affected?
- Distributed: US Nationwide , Alaska, and Puerto Rico.. The recall covers these lots — Batch # 6402413, Exp Date: 02/29/2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0424-2026.