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Class I · Most seriousRecall completed

Atovaquone

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot # 2310083, Exp. 09/30/2025
Where it was soldNationwide in the U.S.A.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byBionpharma Inc.
Brand nameATOVAQUONE
Generic nameATOVAQUONE
Active ingredient(s)ATOVAQUONE
Distributed by / forBionpharma Inc., Princeton, NJ 08540
NDC69452-252-87
Show the full FDA record
Full product labelAtovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
Recalling firmBionpharma Inc.
DistributionNationwide in the U.S.A.
Quantity1,980 bottles
Recall initiated2024-09-17
Report date2024-10-23
Recall completed2025-09-16
Recall numberD-0012-2025
ClassificationClass I
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.