{"url_path":"/fda/drug/recalls/D-0526-2026","section_key":"summary","section_title":"DRUG Recall: Hikma Pharmaceuticals USA INC — Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-07","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0526-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Hikma Pharmaceuticals USA INC"},"word_count":95,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0526-2026\n\n**Recalling firm:** Hikma Pharmaceuticals USA INC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-07\n**Report date:** 2026-05-06\n\n## Product\nAlendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.\n\n## Reason\nThis recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.\n\n## Affected lots\nLot # AC2040A, Exp Date: 04/2026\n\n## Distribution\nUS Nationwide."}