{"url_path":"/fda/drug/recalls/D-0477-2026","section_key":"summary","section_title":"DRUG Recall: SUN PHARMACEUTICAL INDUSTRIES INC — Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-03-25","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0477-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"SUN PHARMACEUTICAL INDUSTRIES INC"},"word_count":89,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0477-2026\n\n**Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-25\n**Report date:** 2026-04-22\n\n## Product\nFluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.\n\n## Reason\nFailed Viscosity Specifications:  Out of Specification results, above the specification limit, in viscosity, noted during stability testing.\n\n## Affected lots\nLot# AD76250, Exp Date: 6/30/2026.\n\n## Distribution\nNationwide in the USA."}