Atovaquone Oral Suspension Recalled Due to Potential Bacillus Contamination
AvKARE recalls Atovaquone Oral Suspension due to potential Bacillus cereus contamination of a non-sterile product. The recalled lot (AW0221A, Exp. 08/30/2025) was distributed nationwide; 153 cartons affected.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification establishes this as Severe (4) per the rubric. No deaths or serious injuries are reported, so the score does not reach Critical (5).
Plain-English summary
AvKARE, Inc. is recalling Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets (NDC 50268-086-12) due to potential Bacillus cereus contamination of the non-sterile product.
The recalled lot is AW0221A with an expiration date of 08/30/2025. A total of 153 cartons were distributed throughout the United States.
Bacillus cereus is a pathogenic microorganism capable of causing infection.
The recalled product
- 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.
- Manufacturer
- AvKARE
- Category
- Drug — Oral Suspension
- Hazard
- Affected units
- 153
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: AW0221A Exp. 08/30/2025
Distribution
Distributed nationwide across the United States.
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