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FDA recall, , High risk

B. Braun 0.9% Sodium Chloride Injection

0.9% Sodium Chloride Injection contains particulate matter that can cause life-threatening health consequences.

What happened

B. Braun Medical Inc, of Allentown, Pennsylvania, is voluntarily recalling 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. The recall, begun on August 19, 2026, and announced on August 27, 2026, covers 201,472 total containers distributed nationwide within the United States. The product contains particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene.

The recall was added to the FDA's Enforcement Report on September 10, 2026, and classified on September 22, 2026. The product is described by B. Braun Medical Inc., Bethlehem, PA 18018 USA.

What to do

If a code on your package is listed below:

  1. Customers that have the recalled product should return to place of purchase.
  2. Consumers with questions regarding this recall can contact B. Braun by emailing recalls@bbraunusa.com, Monday to Friday 8:00am to 5:00pm EST.
  3. Contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this drug product.

Is yours affected?

Match the lot code, best-by or expiration date and NDC listed under your product.

An NDC (National Drug Code) is usually printed on the drug's label.

  1. B Braun 0.9% Sodium Chloride Injection USP

    NDC
    • 0264-1800
    • 32
    Lot code
    • J6B435
    • J6B444
    • J6B457
    Best-by or expiration date
    30APR2027

Recall details

Company began the recall
Sold in

Nationwide within the United States

Company
B Braun Medical IncAllentown, Pennsylvania
Risk

High risk

There is a reasonable chance that taking it could cause serious health problems or death.

FDA Class I recall · How risk is rated

Event ID
99703
Recall number
D-0869-2026
Quantity recalled
201,472 total container

All recalls from B Braun Medical Inc

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Announced by the company

  3. Listed on Recall Canary

  4. Added to FDA's Enforcement Report

  5. In FDA's weekly enforcement report

  6. Classified by FDA

  7. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 7, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)