Fyarro (albumin-bound)
Failed Stability Specifications
Most common reason: Sterility / contamination (7 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Albumin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Failed Stability Specifications
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Lack of Assurance of Sterility
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Lack of Assurance of Sterility
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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