FDA Drugs recall ·
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000… recall
- Recall number
- D-0433-2026
- Date
- (initiated March 11, 2026)
- Company / brand
- Fresenius Kabi USA, LLC
3 Corporate Dr, Lake Zurich, IL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.
Why was it recalled?
Lack of Assurance of Sterility
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Batch# 23SU10001, Exp Date: 12/31/2026; Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027; Batch # 24EU10001, 24EU10002, Exp Date: 05/31/2027; Batch# 24PU10002, Exp Date: 11/30/2027; Batch# 25BU10003, Exp Date: 02/29/2028; Batch# 25EU10005, Exp Date: 05/31/2028.
Distribution
US Nationwide , Alaska, and Puerto Rico.
States: Alaska Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0433-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.