Reported Jul 2, 2025 · Ongoing

0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham,…

Fresenius Medical Care Holdings, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St Bld 920 · Waltham, MA · 02451-1521

Is this the product you have?

  • 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Lot codes and dates
  • 161 of 161 codes

    • 24PU06037
    • 24PU06038
    • 24PU06040
    • 24PU06041
    • 24PU06042
    • 24PU06043
    • 24PU06044
    • 24PU06045
    • 24PU0646
    • 24PU06047
    • 24PU06048
    • 24PU06049
    • 24PU06050
    • 24PU06052
    • 24PU06053
    • 24PU06054 & 24PU06055
    • Exp Date 11/30/2025
    • 24SU06001
    • 24SU06002
    • 24SU06003
    • 24SU06004
    • 24SU06005
    • 24SU06006
    • 24SU06007
    • 24SU06009
    • 24SU06010
    • 24SU06011 24SU06012
    • 24SU06013
    • 24SU06014
    • 24SU06015
    • 24SU06016
    • 24SU06017
    • 24SU06018
    • 24SU06019
    • 24SU06020
    • 24SU06021
    • 24SU06022
    • 24SU06023
    • 24SU06024
    • 24SU06025
    • 24SU06026
    • 24SU06028
    • 24SU06029
    • 24SU06030
    • 24SU06031
    • 24SU06032
    • 24SU06033 24SU06034
    • 24SU06035
    • 24SU06036
    • 24SU06037
    • 24SU06038
    • 24SU06039
    • 24SU06040
    • 24SU06041
    • 24SU06042
    • 24SU06043
    • 24SU06044
    • 24SU06045
    • 24SU06046
    • 24SU06047
Amount recalled
3,651,468 containers

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 4:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.