AvKARE recalls Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE,
AvKARE recalls 20-unit Atovaquone Oral Suspension sachets due to potential Bacillus cereus contamination. This non-sterile product may cause illness if used.
Lower-risk recall
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Contact the company & request your remedy
What happened, in plain English
AvKARE is recalling atovaquone oral suspension sachets that may contain Bacillus cereus bacteria. Using these products could lead to illness since they are not sterile. Read more at govinfonow.com/recall/32752-avkare-atovaquone-oral-suspension-recall-microbial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32752-avkare-atovaquone-oral-suspension-recall-microbial-contamination-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0444-2024
Cite this page
“AvKARE Atovaquone Oral Suspension Recall: Microbial Contamination Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32752-avkare-atovaquone-oral-suspension-recall-microbial-contamination-risk. Based on FDA recall #D-0444-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0444-2024%22&limit=1).
Why it’s dangerous
The medication may have been contaminated with Bacillus cereus bacteria during production. This non-sterile product could cause illness if taken, as it is not meant to be sterile.
Who’s affected
People prescribed this medication by a doctor who received the recalled product. Those with compromised immune systems are at higher risk.
How to tell if you have this one
Check for the product name 'Atovaquone Oral Suspension USP', 750 mg per 5 mL sachets, 20 units in a 5 mL carton. The lot number is AW0221A with an expiration date of 08/30/2025.
- Brand
AvKARE- Category
Drug
What to do — step by step
Check Product Details
Look for the product name, 750 mg per 5 mL sachets, 20 units in a carton, and lot number AW0221A with expiration 08/30/2025.
Questions people ask
Is this product safe to use?
The product may contain Bacillus cereus bacteria and is not sterile, so it could cause illness if used.
How can I tell if I have the recalled product?
Check for the product name 'Atovaquone Oral Suspension USP', 750 mg per 5 mL sachets, 20 units in a carton, and lot number AW0221A with expiration 08/30/2025.
What should I do if I have this product?
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance.
Contact AvKARE
We’ve drafted a message you can send AvKARE to request your refund or repair — edit it as you like.
Subject: Recall D-0444-2024 — AvKARE AvKARE Hello, I own a AvKARE that is covered by recall D-0444-2024 from AvKARE. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0444-2024 (March 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0444-2024 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.