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FDA recall announcement

0.9% recall 2026

Otsuka ICU Medical LLC announced a recall of 0.9% Sodium Chloride Injection, USP, 100 mL. FDA lists the reason as: Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection

A specific recall was announced.

Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection

FDA publish date
September 21, 2026
Company
Otsuka ICU Medical LLC
Product
0.9% Sodium Chloride Injection, USP, 100 mL
Last checked
September 23, 2026
NDC / identifier
No specific identifier listed in this announcement
Affected lot(s)
No specific lot listed for this clarification

What the FDA announcement says

Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection

Read the original FDA recall announcement →

What to check on the package

  1. Confirm the exact product and brand name.
  2. Compare the manufacturer or distributor.
  3. Match the NDC or product identifier.
  4. Match the lot or code exactly; a drug name alone is not enough.

What to do

Compare the exact product, company, identifier, and lot with the FDA announcement. Follow the recalling company or FDA instructions for affected products.

Do not stop or change a prescribed medication based only on this page. Contact a pharmacist, prescriber, or the recalling company for instructions specific to your product.

Related FDA enforcement records

59 matching records appear in the current 24-month openFDA snapshot. Use the search tool to compare the exact manufacturer, NDC, and lot.

Search all records for 0.9% →

Source and limitations

This server-rendered page summarizes an FDA source and the openFDA enforcement snapshot last checked on September 23, 2026. It is not an FDA service and does not provide individual medical advice.