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FDA recall announcement

Morphine Sulfate recall 2026

Fresenius Kabi announced a recall of Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL. FDA lists the reason as: Due to a label mix-up

A specific recall was announced.

Due to a label mix-up

FDA publish date
August 5, 2026
Company
Fresenius Kabi
Product
Morphine Sulfate Injection USP, Simplist® 2 mg/1 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

Due to a label mix-up

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

44 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 Morphine Sulfate →

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.