CLASS I Drug recall · Reported 24 Apr 2024 · FDA Enforcement Report
Atovaquone Oral Suspension USP, 750 mg per sachets recalled by AvKARE
AvKARE is recalling Atovaquone Oral Suspension USP, 750 mg per sachets x, distributed nationwide in the US. The recall was initiated on 28 Mar 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0444-2024
- FDA event ID
- 94329
- Recalling firm
- AvKARE, Pulaski, TN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 28 Mar 2024
- FDA classified
- 16 Apr 2024
- Reported
- 24 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Bacterial Contamination
Timeline
| 28 Mar 2024 | Recall initiated by company | |
| 16 Apr 2024 | Classified by FDA | +19 days |
| 24 Apr 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Which lots are affected?
Lot: AW0221A Exp. 08/30/2025
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Atovaquone recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Atovaquone Oral Suspension, USP 750 mg recalled by BionpharmaAtovaquone | Bionpharma | Sterility | Nationwide |
| Drug | CLASS I | Atovaquone Oral Suspension USP, 750 mg recalledAtovaquone | Camber Pharmaceuticals | Other Bacterial Contamination | Nationwide |
| Drug | CLASS I | Atovaquone Oral Suspension, USP, 750 mg recalled by KVK-TechAtovaquone Oral Suspension | Kvk-Tech | Temperature Abuse | Nationwide |