{"recall":{"id":"fda-drug-99312","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Reliance Life Sciences Private Limited recalls 4 products","firm":"Reliance Life Sciences Private Limited","date":"2026-06-24","reported":"2026-07-15","status":"Ongoing","classification":"Class II","products":[{"name":"Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01","code":"Lot, expiry: RPTL0325A Dec 31, 2027; RPTL0425A Dec 31, 2027; RPTL0624B Nov 30,2027; RPTL0625A Mar 31, 2028","quantity":"12,000 vials","number":"D-0671-2026","classification":"Class II"},{"name":"Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01","code":"Lot, expiry: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 2028;","quantity":"5,020 vials","number":"D-0672-2026","classification":"Class II"},{"name":"Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01","code":"Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028","quantity":"11,400 vials","number":"D-0673-2026","classification":"Class II"},{"name":"Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01","code":"Lot, expiry: RAZM0425A Jun 30, 2027; RAZM0525A Jun 30, 2027; RAZM0725A Jun 30, 2027; RAZM0825A Jun 30, 2027; RAZM0925A Jul 31, 2027; RAZM1125A Jul 31, 2027; RAZM1225A Jul 31, 2027; RAZM1425A Jul 31, 2027; RAZM1525A Jul 31, 2027; RAZM1625A Aug 31, 2027; RAZM1725A Aug 31, 2027; RAZM2025A Sep 30, 2027","quantity":"8,001 vials","number":"D-0674-2026","classification":"Class II"}],"reason":"Lack of Sterility Assurance","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide in the USA","nationwide":true,"states":[],"units":"12,000 vials; 5,020 vials; 11,400 vials; 8,001 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=99312","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"04427805db12c8c1","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=99312","record":[{"status":"Ongoing","city":"Navi Mumbai","state":"N/A","country":"India","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99312","recalling_firm":"Reliance Life Sciences Private Limited","address_1":"Ttc Area Of Midc","address_2":"R - 282 Dhirubhai Ambani Life Sciences Centre; Thane Belapur Road","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide in the USA","recall_number":"D-0671-2026","product_description":"Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only,  Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01","product_quantity":"12,000 vials","reason_for_recall":"Lack of Sterility Assurance","recall_initiation_date":"20260624","center_classification_date":"20260708","report_date":"20260715","code_info":"Lot, expiry:     RPTL0325A Dec 31, 2027;   RPTL0425A Dec 31, 2027;   RPTL0624B Nov 30,2027;   RPTL0625A Mar 31, 2028"},{"status":"Ongoing","city":"Navi Mumbai","state":"N/A","country":"India","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99312","recalling_firm":"Reliance Life Sciences Private Limited","address_1":"Ttc Area Of Midc","address_2":"R - 282 Dhirubhai Ambani Life Sciences Centre; Thane Belapur Road","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide in the USA","recall_number":"D-0672-2026","product_description":"Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only,  Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01","product_quantity":"5,020 vials","reason_for_recall":"Lack of Sterility Assurance","recall_initiation_date":"20260624","center_classification_date":"20260708","report_date":"20260715","code_info":"Lot, expiry:            RPTH0125A Jan 31, 2028;   RPTH0225A Jan 31, 2028;   RPTH0325A Jan 31, 2028;   RPTH0725A Apr 30, 2028;"},{"status":"Ongoing","city":"Navi Mumbai","state":"N/A","country":"India","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99312","recalling_firm":"Reliance Life Sciences Private Limited","address_1":"Ttc Area Of Midc","address_2":"R - 282 Dhirubhai Ambani Life Sciences Centre; Thane Belapur Road","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide in the USA","recall_number":"D-0673-2026","product_description":"Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01","product_quantity":"11,400 vials","reason_for_recall":"Lack of Sterility Assurance","recall_initiation_date":"20260624","center_classification_date":"20260708","report_date":"20260715","code_info":"Lot, expiry:     RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028"},{"status":"Ongoing","city":"Navi Mumbai","state":"N/A","country":"India","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"99312","recalling_firm":"Reliance Life Sciences Private Limited","address_1":"Ttc Area Of Midc","address_2":"R - 282 Dhirubhai Ambani Life Sciences Centre; Thane Belapur Road","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide in the USA","recall_number":"D-0674-2026","product_description":"Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous  and Intravenous Use, Rx only,  Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01","product_quantity":"8,001 vials","reason_for_recall":"Lack of Sterility Assurance","recall_initiation_date":"20260624","center_classification_date":"20260708","report_date":"20260715","code_info":"Lot, expiry:            RAZM0425A  Jun 30, 2027;   RAZM0525A Jun 30, 2027;   RAZM0725A Jun 30, 2027;   RAZM0825A Jun 30, 2027;   RAZM0925A Jul 31, 2027;   RAZM1125A Jul 31, 2027;   RAZM1225A Jul 31, 2027;   RAZM1425A Jul 31, 2027;   RAZM1525A Jul 31, 2027;   RAZM1625A Aug 31, 2027;   RAZM1725A Aug 31, 2027;   RAZM2025A Sep 30, 2027"}]}}