drugs MODERATE Updated 2026-04-15

Fresenius Kabi USA, LLC recalls 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL

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Recalled 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).

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Hazard / Issue

Lack of Assurance of Sterility

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Batch # 6402413, Exp Date: 02/29/2028

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall