{"url_path":"/fda/drug/recalls/D-0523-2026","section_key":"summary","section_title":"DRUG Recall: Acella Pharmaceuticals, LLC — NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada  NDC 42192-619-16","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-20","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0523-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Acella Pharmaceuticals, LLC"},"word_count":76,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0523-2026\n\n**Recalling firm:** Acella Pharmaceuticals, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-20\n**Report date:** 2026-05-13\n\n## Product\nNAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada  NDC 42192-619-16\n\n## Reason\nChemical contamination; presence of lead and lithium above specification\n\n## Affected lots\nLot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.\n\n## Distribution\nNationwide"}