Severity
Critical
CriticalClass ICompleted
FDA Drug recall · Reported October 18, 2023
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
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Scynexis, Inc. recalled BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and… - a critical-severity action.
BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and… was recalled by Scynexis, Inc. in October 18, 2023. Reason: Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substanc…. Check the official notice for the remedy. Verify recall #D-0042-2024 with the FDA Drug before acting.
The recall
Scynexis, Inc. issued this critical-severity FDA Drug recall-Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substanc….
- Critical
- severity level
- 17K units
- affected scope
- Class I
- classification
- October 18, 2023
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0042-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0042-2024) was formally reported on October 18, 2023, with the manufacturer initiating the action on September 25, 2023. It is classified under Critical severity (Class I), with a current status of Completed. Scynexis, Inc. is listed as the recalling firm, operating out of Jersey City, NJ. Federal records list the affected scope as 17,376.
The documented reason for this recall is: Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound). Distribution data in the federal record shows the product reached: Nationwide in the US.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
17,376
Related Recalls
6
5 from same agency
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
Reason for recall
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Completed |
| Recall number | D-0042-2024 |
| Date reported | October 18, 2023 |
| Date initiated | September 25, 2023 |
| Recalling firm | Scynexis, Inc. |
| Firm location | Jersey City, NJ |
| Affected scope | 17,376 |
| Distribution | Nationwide in the US. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0042-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Scynexis, Inc.. Units affected: 17,376.
Why was this product recalled? ▼
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 18, 2023. Severity: Critical. Recall number: D-0042-2024.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the US..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0042-2024) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 18, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.