Bayer VITRAKVI oral solution recall: Microbial contamination risk
Bayer recalls VITRAKVI oral solution (20mg/mL, 100mL) due to Penicillium brevicompactum contamination found in stability testing. This medication is prescription-only and requires immediate action.
Recall notice
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
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What happened, in plain English
Bayer is recalling VITRAKVI oral solution (20mg/mL, 100mL bottle) because routine testing found Penicillium brevicompactum mold. This medication is prescription-only and must be stopped if it's the recalled batch. Read more at govinfonow.com/recall/33013-bayer-vitrakvi-oral-solution-recall-microbial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33013-bayer-vitrakvi-oral-solution-recall-microbial-contamination-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0145-2024
Cite this page
“Bayer VITRAKVI oral solution recall: Microbial contamination risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33013-bayer-vitrakvi-oral-solution-recall-microbial-contamination-risk. Based on FDA recall #D-0145-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0145-2024%22&limit=1).
Why it’s dangerous
Penicillium brevicompactum mold was detected during routine stability testing. This mold can cause infections in immunocompromised patients who use the medication. The contamination occurred in the manufacturing process.
Who’s affected
Prescription patients using VITRAKVI oral solution (20mg/mL, 100mL bottle) manufactured by Bayer HealthCare. Patients with specific cancer treatments are most at risk.
How to tell if you have this one
Check for the product name 'VITRAKVI', strength '20mg/mL', and size '100 mL bottle'. The NDC code is 50419-392-01 and lot number 2114228 (expires 02/29/2024).
- Brand
Bayer- Category
Drug
What to do — step by step
Check Product Details
Verify the product name, strength, and size to confirm if it matches the recalled VITRAKVI oral solution (20mg/mL, 100mL bottle).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class I
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0145-2024 (November 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0145-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.