{"url_path":"/fda/drug/recalls/D-0521-2026","section_key":"summary","section_title":"DRUG Recall: Teva Pharmaceuticals USA, Inc — Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-06","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0521-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Teva Pharmaceuticals USA, Inc"},"word_count":98,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0521-2026\n\n**Recalling firm:** Teva Pharmaceuticals USA, Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-06\n**Report date:** 2026-04-29\n\n## Product\nClaravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.\n\n## Reason\nFailed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin\n\n## Affected lots\nLots#: 100067507, 100067508, Exp 07/31/2026\n\n## Distribution\nNationwide in the USA, Puerto Rico and Virgin Islands"}