Sodium Chloride IV Injection Recall for Sterility Assurance Concerns
Fresenius Kabi recalled specific batches of 0.9% Sodium Chloride Injection due to lack of sterility assurance. Affected batches were distributed nationwide, Alaska, and Puerto Rico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a parenteral (intravenous) drug with lack of sterility assurance. Although no reported illnesses or injuries are documented in the source, the direct bloodstream route of administration creates significant risk of serious harm if contaminated product were administered. The classification reflects risk-of-harm criteria without reported incidents.
Plain-English summary
Fresenius Kabi USA, LLC has recalled specific batches of 0.9% Sodium Chloride Injection, USP (9 mg per mL, 50 mL intravenous injection) due to lack of assurance of sterility. The affected batches are: 6402372 and 6402374 (expiration date 08/31/2026) and batch 6402437 (expiration date 10/31/2026). These batches were distributed throughout the United States, Alaska, and Puerto Rico.
This product is administered directly into the bloodstream. Healthcare facilities, pharmacies, and patients with affected batches should immediately discontinue use. Patients and healthcare providers should consult with their healthcare provider or pharmacist for guidance on product replacement and any necessary safety follow-up.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Intravenous Injection
- Hazard
- lack-of-sterility
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Batch# 6402372
- 6402374
- Exp Date: 08/31/2026
- Batch# 6402437
- Exp Date: 10/31/2026.
Distribution
Distributed nationwide across the United States.
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