FDA Drugs recall ·
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0012-2025
- Date
- (initiated September 17, 2024)
- Company / brand
- Bionpharma Inc.
400 Alexander Park Ste 2-4b, Princeton, NJ, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Terminated
- Units affected
- 1,980 bottles
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
Why was it recalled?
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 2310083, Exp. 09/30/2025
Distribution
Nationwide in the U.S.A.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0012-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.