Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Albumin recalled?

Not under an active recall. Albumin was recalled 9 times in the past — all now closed. Most recent: Oct 13, 2022.

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.

Albumin recalls on record

none so far in 2026; 9 on record, newest first
Class II · Moderate risk

Draximage MAA

Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.

Terminated Sterility / contamination Jubilant Draximage Inc NDC 65174-270-30 D-1189-2022
Class II · Moderate risk

C-*Albumin Eye Drop 10% S

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Terminated Sterility / contamination Medical Center Pharmacy, Inc. NDC 44206-0251-05 D-1073-2020
Class II · Moderate risk

Volumex (Iodinated I 131 Albumin)

Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.

Terminated Sterility / contamination Iso-Tex Diagnostics, Inc NDC 50914-7720-8 D-1008-2019
Class II · Moderate risk

Albumin (Bovine)

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.

Terminated Cross-contamination Attix Pharmaceuticals D-505-2015