{"url_path":"/fda/drug/recalls/D-0809-2026","section_key":"summary","section_title":"DRUG Recall: Baxter Healthcare Corporation — Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-5197-41.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-08-06","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0809-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Baxter Healthcare Corporation"},"word_count":84,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0809-2026\n\n**Recalling firm:** Baxter Healthcare Corporation\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-08-06\n**Report date:** 2026-09-09\n\n## Product\nFamotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-5197-41.\n\n## Reason\nCGMP Deviations\n\n## Affected lots\nLot # NC188586, Exp Date: 02/28/2027; Lot # NC188913, Exp Date: 3/9/2027.\n\n## Distribution\nUS Nationwide; Puerto Rico; and Chile."}