FDA recall, , Moderate risk
Octapharma Octagam Immune Globulin (Human)
There is the potential for damaged units being on the US market.
Summary by Recall Canary from the FDA notice
What happened
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. is recalling distributed Octagam IVIG 10% 30gm/300mL as the products fell to the ground while a Material Handling Equipment Operator was relocating double-stacked pallets, creating the potential for damaged units being on the US market. The recall began on August 11, 2025, and the products were distributed in California, Kentucky, Mississippi, North Carolina, Ohio and Tennessee.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the batch code and lot code listed under your product.
Immune Globulin (Human); Octagam IVIG 10% 30gm/300mL (
- Batch code
- KP12B8561)
- KP12B8561
- Lot code
- KP12B8561
Recall details
- Company began the recall
- Sold in
- 6 states
- Company
- Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98404
- Recall number
- B-0152-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
