{"url_path":"/fda/drug/recalls/D-0544-2026","section_key":"summary","section_title":"DRUG Recall: Zydus Pharmaceuticals (USA) Inc — Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-29","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0544-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Zydus Pharmaceuticals (USA) Inc"},"word_count":101,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0544-2026\n\n**Recalling firm:** Zydus Pharmaceuticals (USA) Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-29\n**Report date:** 2026-05-27\n\n## Product\nErythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).\n\n## Reason\nCGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit\n\n## Affected lots\nLots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.\n\n## Distribution\nNationwide within the U.S"}