CLASS I ONGOING Drug recall · Reported 16 Sep 2026 · FDA Enforcement Report

0.9% Sodium Chloride Injection, USP Partial Fill recalled

B Braun Medical is recalling 0.9% Sodium Chloride Injection, USP Partial Fill in PAB Container, Sterile, distributed nationwide in the US. The recall was initiated on 19 Aug 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.

NDC0264-1800

Quantity recalled201,472 total container

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0869-2026
FDA event ID: 99703
Recalling firm: B Braun Medical, Allentown, PA
Brand: Sodium Chloride
Manufacturer: B. Braun Medical Inc.
Classification: Class I
Status: Ongoing
Recall initiated: 19 Aug 2026
FDA classified: 22 Sep 2026
Reported: 16 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Injectable & IV Drugs

Timeline

19 Aug 2026	Recall initiated by company
16 Sep 2026	Published in enforcement report	+28 days
22 Sep 2026	Classified by FDA	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene

Product as listed by the FDA

0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene

Which lots are affected?

Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Sodium Chloride recalls

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Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride	Baxter Healthcare	Particulate Matter	IL
2 Sep 2026Drug	CLASS I	Lactated Ringer's Injection USP Excel container recalledLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
13 May 2026Drug	CLASS I	Lactated Ringer's Injection USP container recalled by B Braun MedicalLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
29 Apr 2026Drug	CLASS II	Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation	B Braun Medical	Sterility	Nationwide
22 Apr 2026Drug	CLASS II	0.9% Sodium Chloride Injection, USP Ampules recalled by Huons CoSodium Chloride	Huons	Sterility	Nationwide