CLASS I Drug recall · Reported 23 Oct 2024 · FDA Enforcement Report
Atovaquone Oral Suspension, USP 750 mg recalled by Bionpharma
Bionpharma is recalling Atovaquone Oral Suspension, USP 750 mg, distributed nationwide in the US. The recall was initiated on 17 Sep 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-0012-2025
- FDA event ID
- 95345
- Recalling firm
- Bionpharma, Princeton, NJ
- Brand
- Atovaquone
- Manufacturer
- Bionpharma Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Sep 2024
- FDA classified
- 15 Oct 2024
- Reported
- 23 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
Timeline
| 17 Sep 2024 | Recall initiated by company | |
| 15 Oct 2024 | Classified by FDA | +28 days |
| 23 Oct 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: The product was found to be contaminated with Cohnella bacteria.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
Where it was distributed
Nationwide in the U.S.A.
Questions about this recall
Why was it recalled?
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Which lots are affected?
Lot # 2310083, Exp. 09/30/2025
Where was it sold?
Nationwide in the U.S.A.
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.
More recalls from Bionpharma
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Doxylamine Succinate and Pyridoxine HCl Delayed-Release recalledDoxylamine Succinate And Pyridoxine Hydrochloride | Bionpharma | Other | Nationwide |
| Drug | CLASS II | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg recalledDivalproex Sodium | Bionpharma | Other | Nationwide |
| Drug | CLASS II | Clobazam Oral Suspension, 2.5 mg/mL recalled by BionpharmaClobazam | Bionpharma | Sterility | Nationwide |
Other Atovaquone recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Atovaquone Oral Suspension USP, 750 mg per sachets recalled by AvKARE | AvKARE | Other Bacterial Contamination | 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 |