Recall archive / FDA company announcement

BionPharma: Atovaquone Oral Suspension, 750 mg/mL — FDA announcement Sep 18, 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 Sep 18, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Atovaquone Oral Suspension, 750 mg/mL
Reason: Product found to be contaminated with Cohnella bacteria
Classification: Not supplied
Recalling firm: Bionpharma Inc.
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: 71e6495e2239c734

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE – September 17, 2024 – Princeton, NJ, Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be contaminated with Cohnella bacteria.; We take these findings seriously and are taking immediate action to address the situation. We have initiated a recall of the (1) affected batch listed below and are implementing enhanced quality control measures with our manufacturer, CoreRx, Inc. to prevent recurrence. Our priority remains the safety and well-being of our consumers, and we are committed to transparency throughout this process.; This product is a quinone antimicrobial drug indicated for prevention of pneumocycstis jirovecii pneumonia (formerly known as PCP for pneumocystis carinii pneumonia) in adults and adolescents aged 13 and older. The affected batch of product was manufactured at CoreRx, Inc. and shipped nationwide to our customers between December 21, 2023 and June 20, 2024 and distributed through wholesalers and retailers. The recall includes the following product and batch number:; The lot number can be obtained from the side panel of the bottle or the bottom flap of the carton.; The Company is notifying its distributors and customers by email and is arranging for return/replacement etc. of the recalled batch of the product. Distributors/retailers that have affected lot of the drug product which is being recalled should immediately cease distribution and remove it from active inventory. Consumers that have the affected lot of the product should stop using the product and return to the place of purchase; Consumers with questions regarding this recall can contact Bionpharma by phone at (888) 235-2466 (Mon-Fri 9AM-5PM EST) or via email to [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the affected lot of the drug product; Production Date \| Release Date \| Product Name \| NDC \| Lot No. \| Expiration Date; October 26, 2023 \| December 05, 2023 \| Atovaquone Oral Suspension \| 69452-252-87 \| 2310083 \| September 2025

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE – September 17, 2024 – Princeton, NJ, Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be contaminated with Cohnella bacteria.; We take these findings seriously and are taking immediate action to address the situation. We have initiated a recall of the (1) affected batch listed below and are implementing enhanced quality control measures with our manufacturer, CoreRx, Inc. to prevent recurrence. Our priority remains the safety and well-being of our consumers, and we are committed to transparency throughout this process.; This product is a quinone antimicrobial drug indicated for prevention of pneumocycstis jirovecii pneumonia (formerly known as PCP for pneumocystis carinii pneumonia) in adults and adolescents aged 13 and older. The affected batch of product was manufactured at CoreRx, Inc. and shipped nationwide to our customers between December 21, 2023 and June 20, 2024 and distributed through wholesalers and retailers. The recall includes the following product and batch number:; The lot number can be obtained from the side panel of the bottle or the bottom flap of the carton.; The Company is notifying its distributors and customers by email and is arranging for return/replacement etc. of the recalled batch of the product. Distributors/retailers that have affected lot of the drug product which is being recalled should immediately cease distribution and remove it from active inventory. Consumers that have the affected lot of the product should stop using the product and return to the place of purchase; Consumers with questions regarding this recall can contact Bionpharma by phone at (888) 235-2466 (Mon-Fri 9AM-5PM EST) or via email to [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the affected lot of the drug product; Production Date | Release Date | Product Name | NDC | Lot No. | Expiration Date; October 26, 2023 | December 05, 2023 | Atovaquone Oral Suspension | 69452-252-87 | 2310083 | September 2025

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

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
Production Date	Release Date	Product Name	NDC	Lot No.	Expiration Date
October 26, 2023	December 05, 2023	Atovaquone Oral Suspension	69452-252-87	2310083	September 2025

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Fda listing date: Sep 18, 2024
Company announcement date: Sep 17, 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.