{"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","discovered_at":"2026-05-14T18:03:26.108348+00:00","generated_at":"2026-06-06T03:47:05.594557+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.3,"calibrated_materiality_score":0.3,"confidence":"high","headline":"Biofrontera announces voluntary recall of limited Ameluz® lots due to packaging defect","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-005946","json":"https://secwatch.observer/filing/0001493152-24-005946.json","markdown":"https://secwatch.observer/filing/0001493152-24-005946.md","text":"https://secwatch.observer/filing/0001493152-24-005946.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-06T03:47:05.594557+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}