{"url_path":"/fda/drug/recalls/D-0484-2026","section_key":"summary","section_title":"DRUG Recall: Hetero Labs Limited (Unit V) — Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-03-26","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0484-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Hetero Labs Limited (Unit V)"},"word_count":95,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0484-2026\n\n**Recalling firm:** Hetero Labs Limited (Unit V)\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-26\n**Report date:** 2026-04-29\n\n## Product\nPantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10\n\n## Reason\nDiscoloration: Firm received five (5) complaints stating that, \"Tablets discolored darker than normal and have lighter-colored spots.\"\n\n## Affected lots\nBatch # FD253967, Exp Date: 06/26/2027\n\n## Distribution\nNationwide in the USA."}