Scynexis Brexafemme tablets Recall: FDA Class I

Why it was recalled

Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).

Product description

BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04

Lot numbers, UPCs & expiration codes

Lot# LF21000008, Exp. 11/30/2023 Lot# LF22000051, Exp. 11/30/2025

Where it was sold

Nationwide in the US.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0042-2024
Classification: Class I
Status: Completed
Recall initiated: Sep 25, 2023
FDA report date: Oct 18, 2023
Quantity: 17,376
Recall type: Voluntary: Firm initiated
Recalling firm: Scynexis, Inc.

Original FDA data

Every field from FDA enforcement report D-0042-2024, exactly as published.

Show all FDA fields

City: Jersey City
State: NJ
Status: Completed
Country: United States
Event ID: 93113
Address: 1 Evertrust Plz Fl 13
Code information: Lot# LF21000008, Exp. 11/30/2023 Lot# LF22000051, Exp. 11/30/2025
Postal code: 07302-3051
Report date: Oct 18, 2023
Product type: Drugs
Recall number: D-0042-2024
Classification: Class I
Recalling firm: Scynexis, Inc.
Product quantity: 17,376
Reason for recall: Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Voluntary / mandated: Voluntary: Firm initiated
Product description: BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04
Distribution pattern: Nationwide in the US.
Recall initiation date: Sep 25, 2023
Initial firm notification: E-Mail
Center classification date: Oct 6, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0042-2024, published Oct 18, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Scynexis Brexafemme Recall

Summary