{"recall":{"id":"fda-drug-99530","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Shilpa Medicare Limited recalls 2 products","firm":"Shilpa Medicare Limited","date":"2026-07-29","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1","code":"Lot: P400172; Lot PA00050A, Exp 09/30/2027","quantity":"18,434 10mL vials","number":"D-0764-2026","classification":"Class II"},{"name":"PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1","code":"Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027","quantity":"9,489 50mL vials","number":"D-0765-2026","classification":"Class II"}],"reason":"Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide in the USA.","nationwide":true,"states":[],"units":"18,434 10mL vials; 9,489 50mL vials","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99530","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"368b4f58b998e571","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99530","record":[{"status":"Ongoing","city":"Jadcherla, Mahabubnagar District","state":"","country":"India","classification":"Class II","openfda":{"application_number":["NDA215179"],"brand_name":["PEMRYDI RTU"],"generic_name":["PEMETREXED DISODIUM"],"manufacturer_name":["Amneal Pharmaceuticals LLC"],"product_ndc":["70121-2453","70121-2461","70121-2462"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["PEMETREXED DISODIUM HEMIPENTAHYDRATE"],"rxcui":["2637958","2637964","2637966","2637967","2637968","2637969"],"spl_id":["b6a00be1-95d1-4b91-93bf-4430a57eeff6"],"spl_set_id":["0f006b06-ab85-423d-ba0c-dfc3fc25844e"],"package_ndc":["70121-2453-1","70121-2461-1","70121-2462-1"],"is_original_packager":[true],"upc":["0370121246213","0370121246114","0370121245315"],"unii":["F4GSH45R4C"]},"product_type":"Drugs","event_id":"99530","recalling_firm":"Shilpa Medicare Limited","address_1":"Plot No. S20 to S26, Pharmaceutical Formulations SEZ","address_2":"TSIIC Green Industrial Park, Polepally (Village)","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide in the USA.","recall_number":"D-0764-2026","product_description":"PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL),  Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807.  NDC: 70121-2453-1","product_quantity":"18,434 10mL vials","reason_for_recall":"Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials","recall_initiation_date":"20260729","center_classification_date":"20260814","report_date":"20260826","code_info":"Lot: P400172; Lot PA00050A, Exp 09/30/2027","more_code_info":""},{"status":"Ongoing","city":"Jadcherla, Mahabubnagar District","state":"","country":"India","classification":"Class II","openfda":{"application_number":["NDA215179"],"brand_name":["PEMRYDI RTU"],"generic_name":["PEMETREXED DISODIUM"],"manufacturer_name":["Amneal Pharmaceuticals LLC"],"product_ndc":["70121-2453","70121-2461","70121-2462"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["PEMETREXED DISODIUM HEMIPENTAHYDRATE"],"rxcui":["2637958","2637964","2637966","2637967","2637968","2637969"],"spl_id":["b6a00be1-95d1-4b91-93bf-4430a57eeff6"],"spl_set_id":["0f006b06-ab85-423d-ba0c-dfc3fc25844e"],"package_ndc":["70121-2453-1","70121-2461-1","70121-2462-1"],"is_original_packager":[true],"upc":["0370121246213","0370121246114","0370121245315"],"unii":["F4GSH45R4C"]},"product_type":"Drugs","event_id":"99530","recalling_firm":"Shilpa Medicare Limited","address_1":"Plot No. S20 to S26, Pharmaceutical Formulations SEZ","address_2":"TSIIC Green Industrial Park, Polepally (Village)","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide in the USA.","recall_number":"D-0765-2026","product_description":"PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807.  NDC: 70121-2461-1","product_quantity":"9,489 50mL vials","reason_for_recall":"Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials","recall_initiation_date":"20260729","center_classification_date":"20260814","report_date":"20260826","code_info":"Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027","more_code_info":""}]}}