Class II · ModerateActive recall
Sodium Chloride
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberBatch# 6402299, 6402300, 6402301, 6402302, 6402303, Exp Date: 01/31/2027; Batch# 6402305, 6402398, Exp Date: 02/28/2027; Batch# 6402467, Exp Date: 04/30/2027; Batch# 6402577, 6402578, Exp Date: 06/30/2027.
Where it was soldUS Nationwide , Alaska, and Puerto Rico.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Lack of Assurance of Sterility
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byFresenius Kabi USA, LLC
| Brand name | SODIUM CHLORIDE |
| Generic name | SODIUM CHLORIDE |
| Active ingredient(s) | SODIUM CHLORIDE |
| Distributed by / for | Fresenius Kabi USA, LLC |
| NDC | 65219-468-05 |
Show the full FDA record
| Full product label | 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50. |
| Recalling firm | Fresenius Kabi USA, LLC |
| Distribution | US Nationwide , Alaska, and Puerto Rico. |
| Recall initiated | 2026-03-11 |
| Report date | 2026-04-15 |
| Recall completed | — |
| Recall number | D-0426-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Lake Zurich IL United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.