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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- bacillus-cereus
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.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- ModerateVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27