FDA recall, , Low risk
Alba Bioscience Ortho Sera Papain
ORTHO Sera Papain has reduced reactivity, which may cause hemolytic transfusion reactions.
Recall ended Jul 23, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
ALBA Bioscience Limited is recalling ORTHO Sera Papain, Code 6904840, due to reduced reactivity, which may result in blood products being administered that result in hemolytic transfusion reactions. The recall began July 3, 2025, and was added to the FDA's Enforcement Report on May 5, 2026.
The product was distributed in Alabama, Arkansas, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Wisconsin and Wyoming.
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?
Affected if its lot code matches.
ORTHO Sera Papain
- Lot code
- V278742
Recall details
- Company began the recall
- Sold in
- 30 states
- Company
- ALBA Bioscience Limited
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 97216
- Recall number
- B-0049-2026
All recalls from ALBA Bioscience Limited
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
Recall ended
Listed on Recall Canary
Archived
