Scynexis, Inc. is conducting a voluntary nationwide recall of 2 lots of BREXAFEMME® (ibrexafungerp tablets) to the consumer level in the US market due to potential cross contamination with a non-antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the BREXAFEMME® tablets.

Risk Statement: The potential cross contamination with a non-antibacterial beta-lactam drug substance could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life-threatening adverse reaction. To date, SCYNEXIS has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination.

The affected BREXAFEMME® lots include the following lots and expiration dates: LF21000008 (expiration date 11/2023) and LF22000051 (expiration date 11/2025). The recalled lots were distributed nationwide to wholesalers across the US, beginning in December 2022.

Scynexis is engaging with Sedgwick to manage the recall of the product down to the consumer level. Sedgwick will be notifying BREXAFEMME® distributors via a recall notification letter and will be arranging for the return of the recalled lot from distributors, retailers, and consumers.

Consumers with questions regarding this recall can contact Sedgwick at 1-877-551-7154. Office hours: Monday to Friday, 8:00 AM to 5:00 PM ET.

Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.