{"url_path":"/fda/drug/recalls/D-0519-2026","section_key":"summary","section_title":"DRUG Recall: Teva Pharmaceuticals USA, Inc — Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿  19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, …","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-24","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0519-2026%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":137,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0519-2026\n\n**Recalling firm:** Teva Pharmaceuticals USA, Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-24\n**Report date:** 2026-05-13\n\n## Product\nOctreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿  19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.\n\n## Reason\nLack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.\n\n## Affected lots\nLot: 45011002, Exp. 03/31/2027\n\n## Distribution\nNationwide in the USA"}