{"recall":{"id":"fda-drug-99977","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"SUN PHARMACEUTICAL INDUSTRIES INC recalls 3 products","firm":"SUN PHARMACEUTICAL INDUSTRIES INC","date":"2026-09-25","reported":"2026-10-14","status":"Ongoing","classification":"Class III","products":[{"name":"Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9.","code":"Lot # AD96184, Exp Date: 12/31/2026.","quantity":"N/A","number":"D-0033-2027","classification":"Class III"},{"name":"Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada, NDC 16714-249-02.","code":"Lot # AD96183, Exp Date: 12/31/2026.","quantity":"N/A","number":"D-0034-2027","classification":"Class III"},{"name":"Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-0.","code":"Lot # AD96196, Exp Date: 12/31/2026.","quantity":"N/A","number":"D-0035-2027","classification":"Class III"}],"reason":"Failed Impurities/Degradation Specifications","hazard":"FDA Class III: not likely to cause adverse health consequences (FDA definition).","affected":"US Nationwide.","nationwide":true,"states":[],"units":"N/A; N/A; N/A","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=99977","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"f91d1ffc101aabca","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=99977","record":[{"status":"Ongoing","city":"Princeton","state":"NJ","country":"United States","classification":"Class III","openfda":{"application_number":["ANDA211644"],"brand_name":["TRETINOIN"],"generic_name":["TRETINOIN"],"manufacturer_name":["Sun Pharmaceutical Industries, Inc."],"product_ndc":["51672-1394"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"substance_name":["TRETINOIN"],"rxcui":["106303"],"spl_id":["38ef297e-e4cb-0593-e063-6294a90a324d"],"spl_set_id":["2b0c8ee4-83a5-48f1-809a-9716131f7290"],"package_ndc":["51672-1394-0","51672-1394-9"],"is_original_packager":[true],"nui":["N0000175607","M0018962"],"pharm_class_epc":["Retinoid [EPC]"],"pharm_class_cs":["Retinoids [CS]"],"unii":["5688UTC01R"]},"product_type":"Drugs","event_id":"99977","recalling_firm":"SUN PHARMACEUTICAL INDUSTRIES INC","address_1":"2 Independence Way","address_2":"N/A","postal_code":"08540-6620","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0033-2027","product_description":"Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9.","product_quantity":"N/A","reason_for_recall":"Failed Impurities/Degradation Specifications","recall_initiation_date":"20260925","center_classification_date":"20261008","report_date":"20261014","code_info":"Lot # AD96184, Exp Date: 12/31/2026."},{"status":"Ongoing","city":"Princeton","state":"NJ","country":"United States","classification":"Class III","openfda":{"application_number":["ANDA211644"],"brand_name":["TRETINOIN"],"generic_name":["TRETINOIN"],"manufacturer_name":["NORTHSTAR RX LLC"],"product_ndc":["16714-249"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"substance_name":["TRETINOIN"],"rxcui":["106303"],"spl_id":["39809045-c9fe-0fc5-e063-6394a90a60b0"],"spl_set_id":["2e508351-eca3-427e-8d16-e840a84db0f5"],"package_ndc":["16714-249-01","16714-249-02"],"is_original_packager":[true],"nui":["N0000175607","M0018962"],"pharm_class_epc":["Retinoid [EPC]"],"pharm_class_cs":["Retinoids [CS]"],"unii":["5688UTC01R"]},"product_type":"Drugs","event_id":"99977","recalling_firm":"SUN PHARMACEUTICAL INDUSTRIES INC","address_1":"2 Independence Way","address_2":"N/A","postal_code":"08540-6620","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0034-2027","product_description":"Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada, NDC 16714-249-02.","product_quantity":"N/A","reason_for_recall":"Failed Impurities/Degradation Specifications","recall_initiation_date":"20260925","center_classification_date":"20261008","report_date":"20261014","code_info":"Lot # AD96183, Exp Date: 12/31/2026."},{"status":"Ongoing","city":"Princeton","state":"NJ","country":"United States","classification":"Class III","openfda":{"application_number":["ANDA211644"],"brand_name":["TRETINOIN"],"generic_name":["TRETINOIN"],"manufacturer_name":["Sun Pharmaceutical Industries, Inc."],"product_ndc":["51672-1394"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"substance_name":["TRETINOIN"],"rxcui":["106303"],"spl_id":["38ef297e-e4cb-0593-e063-6294a90a324d"],"spl_set_id":["2b0c8ee4-83a5-48f1-809a-9716131f7290"],"package_ndc":["51672-1394-0","51672-1394-9"],"is_original_packager":[true],"nui":["N0000175607","M0018962"],"pharm_class_epc":["Retinoid [EPC]"],"pharm_class_cs":["Retinoids [CS]"],"unii":["5688UTC01R"]},"product_type":"Drugs","event_id":"99977","recalling_firm":"SUN PHARMACEUTICAL INDUSTRIES INC","address_1":"2 Independence Way","address_2":"N/A","postal_code":"08540-6620","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide.","recall_number":"D-0035-2027","product_description":"Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-0.","product_quantity":"N/A","reason_for_recall":"Failed Impurities/Degradation Specifications","recall_initiation_date":"20260925","center_classification_date":"20261008","report_date":"20261014","code_info":"Lot # AD96196, Exp Date: 12/31/2026."}]}}