FDA Recall D-0424-2026

Fresenius Kabi USA, LLC · Lake Zurich, IL

Class II Ongoing 64 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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).

Lot / code: Batch # 6402413, Exp Date: 02/29/2028

Reason for recall

Lack of Assurance of Sterility

Recall record

Recall number: D-0424-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide , Alaska, and Puerto Rico.
Recall initiated: 2026-03-11
Classified by FDA Center: 2026-04-03
FDA published: 2026-04-15
Recalling firm: Fresenius Kabi USA, LLC
Firm location: Lake Zurich, IL

Drug identification

Brand name(s): SODIUM CHLORIDE
Generic name(s): SODIUM CHLORIDE
Manufacturer(s): Fresenius Kabi USA, LLC
NDC(s): 63323-626
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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