Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
VITRAKVI (larotractenib) oral solution Recalled by Bayer Healthcare Pharmaceuticals Inc. Due to Microbial Contamination of Non-Sterile Products: microbial contamination identified...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bayer Healthcare Pharmaceuticals Inc. directly.
Affected Products
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
Quantity: 192 bottles
Why Was This Recalled?
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bayer Healthcare Pharmaceuticals Inc.
Bayer Healthcare Pharmaceuticals Inc. has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report