> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Bayer Recalls 2 Lots of Kogenate Vials
- URL: https://www.fdaweb.com/bayer-recalls-2-lots-of-kogenate-vials/
- Published: 2019-07-23T12:00:00.000Z
- Updated: 2026-09-15T01:39:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144600

Bayer says it is recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the U.S. to the patient level. A company [statement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-statement-voluntary-recall-two-lots-kogenater-fs-antihemophilic-factor-recombinant-united?ref=fdaweb.com) posted by FDA says that certain vials from the two lots that were labeled as Kogenate FS actually contain the FVIII hemophilia A treatment Jivi antihemophilic factor (recombinant) PEGylated-aucl 3000 IU.

Bayer says the U.S. is the only country where affected products were distributed. The lots were distributed from 2/5 to 7/15 from Bayer distribution sites in Berkeley, CA, and Shawnee, KS.