{"url_path":"/fda/drug/recalls/D-0538-2026","section_key":"summary","section_title":"DRUG Recall: Safecor Health, LLC — Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204.  NDC: 64380-474-01","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-30","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0538-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Safecor Health, LLC"},"word_count":80,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0538-2026\n\n**Recalling firm:** Safecor Health, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-30\n**Report date:** 2026-05-27\n\n## Product\nAtomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204.  NDC: 64380-474-01\n\n## Reason\nLabeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.\n\n## Affected lots\nLot #: 25530722\n\n## Distribution\nTX only"}