---
title: "AVpak: Atovaquone Oral Suspension, USP 750mg/5mL — FDA announcement Apr 1, 2024 | Is It on Recall"
description: "Potential Bacillus cereus contamination"
url: https://isitonrecall.com/recall/fdapress-96ba83b28934370e-avpak-atovaquone-oral-suspension-usp-750mg-5ml/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# AVpak: Atovaquone Oral Suspension, USP 750mg/5mL — FDA announcement Apr 1, 2024

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Apr 1, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Atovaquone Oral Suspension, USP 750mg/5mL
- **Reason**: Potential Bacillus cereus contamination
- **Classification**: Not supplied
- **Recalling firm**: AvKARE, LLC
- **Quantity**: Not supplied
- **Agency-reported status**: Company recall announcement
- **Source record identifier**: 96ba83b28934370e

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-llc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5-ml-due)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | FOR IMMEDIATE RELEASE – 3/29/2024 –AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab.; The product is packaged in a carton. The identified NDC # associated with the product is 50268-086-12, UPC # 5026808612 and the affected lot# is AW0221A with an expiration date of 08/2025. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Fda listing date**: Apr 1, 2024
- **Company announcement date**: Apr 1, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Consumers that have product which is being recalled should stop using the product and return it to place of purchase or discard. Consumers with questions regarding this recall can contact AvKARE by phone at 1-855-361-3993 or email drugsafety@avkare.com, Monday – Friday, 9am – 5pm Eastern Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-llc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5-ml-due)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [AVKARE LLC records](https://isitonrecall.com/brand/avkare-llc/)