Drug FDA Class I Terminated Contamination / non-sterility

Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

Bionpharma Inc. Published Oct 23, 2024

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 80/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Bionpharma Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

Cohnella bacteria · primary

Affected products (1)

Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

ATOVAQUONE · 1,980 bottles

NDC: 69452-252, 69452-252-87

Lot codes: 2310083

Code info: Lot # 2310083, Exp. 09/30/2025

Affected areas

Nationwide

Timeline

Initiated

Sep 17, 2024
Published

Oct 23, 2024
Terminated

Sep 16, 2025

Recall number: D-0012-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.