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# Bayer Recalls 1 Vitrakvi Lot
- URL: https://www.fdaweb.com/bayer-recalls-1-vitrakvi-lot/
- Published: 2023-11-21T12:00:00.000Z
- Updated: 2026-09-14T14:16:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155841

Bayer is recalling one lot of Vitrakvi (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles, indicated for treating solid tumors that are NTRK gene fusion positive, due to microbial contamination identified as *Penicillium brevicompactum* that was detected during routine stability testing.

While there are limited data on human pathology caused by *Penicillium brevicompactum*, a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-issues-voluntary-recall-nationwide-vitrakvir-larotrectinib-oral-solution-20-mgml-due-presence?utm%5Fmedium=email&utm%5Fsource=govdelivery) says, “there are cases of invasive disease caused by similar Penicillium species, particularly in patients with underlying immunosuppression. Therefore, there is a reasonable probability that ingestion of *Penicillium brevicompactum* in patients on Vitrakvi with underlying immunosuppression may result in invasive fungal infections of the blood or pneumonia that can be life-threatening.

To date, Bayer says it has not received any adverse events related to the recall.