Reported Aug 5, 2026 · Ongoing · Updated Sep 16, 2026

Immune Globulin (Human); Octagam IVIG 10% 30gm/300mL (Batch KP12B8561)

Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.

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: Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. · Oberlaaer Strase 235 · Vienna

Is this the product you have?

  • Immune Globulin (Human); Octagam IVIG 10% 30gm/300mL (Batch KP12B8561)
Lot codes and dates
  • Batch KP12B8561
Amount recalled
700

Where it was sold

Why it was recalled

Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. is recalling distributed Octagam IVIG 10% 30gm/300mL (Batch KP12B8561) as they fell to the ground while a Material Handling Equipment Operator was relocating double-stacked pallets. There is the potential for damaged units being on the US market.

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 (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 3:33 PM UTC

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