Atovaquone Oral Suspension recall
FDA recall D-0012-2025 · initiated Sep 17, 2024
Bionpharma Inc. recalled Atovaquone Oral Suspension in Sep 2024 — an FDA Class I recall (D-0012-2025) because Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,980 bottles
Details
- 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.
- Recalling company
- Bionpharma Inc
- Classification
- Class I
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the U.S.A.
- Initiated
- Sep 17, 2024
- FDA report date
- Oct 23, 2024
Frequently asked
- Was Atovaquone Oral Suspension recalled?
- Bionpharma Inc. recalled Atovaquone Oral Suspension in Sep 2024 — an FDA Class I recall (D-0012-2025) because Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Atovaquone Oral Suspension recalled?
- Per the FDA enforcement record, the reason for recall D-0012-2025 was: Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
- Is a recalled Atovaquone Oral Suspension dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Atovaquone Oral Suspension are affected?
- Distributed: Nationwide in the U.S.A.. The recall covers these lots — Lot # 2310083, Exp. 09/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0012-2025.