FDAHealthMarch 11, 2026
Fresenius Kabi USA, LLC — 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 11, 2026
US Nationwide , Alaska, and Puerto Rico.
What's affected?
- Product
- 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.
- Brand
- SODIUM CHLORIDE
- Lot code
- Batch# 6402428, Exp Date: 10/31/2026; Batch# 6402481, 6402482, Exp Date: 11/30/2026.
Additional details
Batch# 6402428, Exp Date: 10/31/2026; Batch# 6402481, 6402482, Exp Date: 11/30/2026.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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