---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-005946"
form_type: "8-K"
ticker: "BFRI"
cik: "0001858685"
company_name: "Biofrontera Inc."
filed_at: "2024-02-13T23:59:59+00:00"
generated_at: "2026-06-06T03:47:05.594557+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.3
calibrated_materiality_score: 0.3
confidence: "high"
source: SEC EDGAR
---

# Biofrontera announces voluntary recall of limited Ameluz® lots due to packaging defect

## Summary
- Licensor Biofrontera AG initiated voluntary recall of limited Ameluz® lots due to packaging manufacturing defect.
- Recalled product not likely to cause adverse health consequences per Licensor.
- Company notifying physician customers and arranging prompt replacement of recalled products.
- Company will not bear any financial responsibility for recall costs; no material financial impact anticipated.

## SEC filing metadata
- accession: 0001493152-24-005946
- form_type: 8-K
- ticker: BFRI
- cik: 0001858685
- company_name: Biofrontera Inc.
- filed_at: 2024-02-13T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.3
- calibrated_materiality_score: 0.3
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1858685/000149315224005946/0001493152-24-005946-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1858685/000149315224005946/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-005946
- JSON: https://secwatch.observer/filing/0001493152-24-005946.json
- Plain text: https://secwatch.observer/filing/0001493152-24-005946.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.