Atovaquone Oral Suspension USP recall
FDA recall D-0444-2024 · initiated Mar 28, 2024
AvKARE recalled Atovaquone Oral Suspension USP in Mar 2024 — an FDA Class I recall (D-0444-2024) because Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
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: 153 cartons
Details
- Product
- Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.
- Recalling company
- AvKARE
- Classification
- Class I
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Mar 28, 2024
- FDA report date
- Apr 24, 2024
Frequently asked
- Was Atovaquone Oral Suspension USP recalled?
- AvKARE recalled Atovaquone Oral Suspension USP in Mar 2024 — an FDA Class I recall (D-0444-2024) because Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Atovaquone Oral Suspension USP recalled?
- Per the FDA enforcement record, the reason for recall D-0444-2024 was: Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
- Is a recalled Atovaquone Oral Suspension USP 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 USP are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot: AW0221A Exp. 08/30/2025. 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-0444-2024.