Home / Recalls / Fresenius Kabi USA, LLC / D-0432-2026

D-0432-2026 Class II Ongoing

Recalled by Fresenius Kabi USA, LLC — Lake Zurich, IL

Recall Details

Product Type
Drugs
Report Date
April 15, 2026
Initiation Date
March 11, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

US Nationwide , Alaska, and Puerto Rico.

Code Information

Batch# 23DU10004, Exp Date: 04/30/2026; Batch# 23HU10006, Exp Date: 06/30/2026.

Other recalls by Fresenius Kabi USA, LLC

  • D-0428-2026 Class II — 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL (March 11, 2026)
  • D-0436-2026 Class II — 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL free (March 11, 2026)
  • D-0430-2026 Class II — 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a (March 11, 2026)
  • D-0426-2026 Class II — 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 (March 11, 2026)
  • D-0424-2026 Class II — 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 25 (March 11, 2026)
  • D-0434-2026 Class II — 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in (March 11, 2026)
  • D-0435-2026 Class II — 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL free (March 11, 2026)
  • D-0433-2026 Class II — 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in (March 11, 2026)
  • D-0425-2026 Class II — 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, (March 11, 2026)
  • D-0427-2026 Class II — 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL (March 11, 2026)