{"recall":{"id":"fda-drug-99330","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Ascend Laboratories, LLC recalls 2 products","firm":"Ascend Laboratories, LLC","date":"2026-06-30","reported":"2026-07-29","status":"Ongoing","classification":"Class III","products":[{"name":"Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.","code":"Lot: 25141707, Exp 4/30/2027.","quantity":"1,753 cartons","number":"D-0735-2026","classification":"Class III"},{"name":"Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.","code":"Lot: 25141584, Exp 4/30/2027.","quantity":"2,717 cartons","number":"D-0736-2026","classification":"Class III"}],"reason":"Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.","hazard":"FDA Class III: not likely to cause adverse health consequences (FDA definition).","affected":"USA Nationwide","nationwide":true,"states":[],"units":"1,753 cartons; 2,717 cartons","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=99330","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"b38cfcfeb3aa21b4","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=99330","record":[{"status":"Ongoing","city":"Bedminster","state":"NJ","country":"United States","classification":"Class III","openfda":{"application_number":["ANDA208040"],"brand_name":["DABIGATRAN ETEXILATE"],"generic_name":["DABIGATRAN ETEXILATE"],"manufacturer_name":["Major Pharmaceuticals"],"product_ndc":["0904-7253","0904-7254","0904-7255"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["DABIGATRAN ETEXILATE MESYLATE"],"rxcui":["1037045","1037179","1723476"],"spl_id":["869fd2f3-9357-4148-8b64-0cca96dd5f75"],"spl_set_id":["b76b79ce-b7dd-4390-b40e-71ae6c477d10"],"package_ndc":["0904-7253-35","0904-7253-04","0904-7253-68","0904-7254-35","0904-7254-68","0904-7255-35","0904-7255-10","0904-7255-68"],"is_original_packager":[true],"upc":["0309047253043","0309047255108"],"unii":["SC7NUW5IIT"]},"product_type":"Drugs","event_id":"99330","recalling_firm":"Ascend Laboratories, LLC","address_1":"135 Us Highway 202 206 Ste 15","address_2":"N/A","postal_code":"07921-2608","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"USA Nationwide","recall_number":"D-0735-2026","product_description":"Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.","product_quantity":"1,753 cartons","reason_for_recall":"Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.","recall_initiation_date":"20260630","center_classification_date":"20260804","report_date":"20260729","code_info":"Lot: 25141707, Exp 4/30/2027."},{"status":"Ongoing","city":"Bedminster","state":"NJ","country":"United States","classification":"Class III","openfda":{"application_number":["ANDA208040"],"brand_name":["DABIGATRAN ETEXILATE"],"generic_name":["DABIGATRAN ETEXILATE"],"manufacturer_name":["Major Pharmaceuticals"],"product_ndc":["0904-7253","0904-7254","0904-7255"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["DABIGATRAN ETEXILATE MESYLATE"],"rxcui":["1037045","1037179","1723476"],"spl_id":["869fd2f3-9357-4148-8b64-0cca96dd5f75"],"spl_set_id":["b76b79ce-b7dd-4390-b40e-71ae6c477d10"],"package_ndc":["0904-7253-35","0904-7253-04","0904-7253-68","0904-7254-35","0904-7254-68","0904-7255-35","0904-7255-10","0904-7255-68"],"is_original_packager":[true],"upc":["0309047253043","0309047255108"],"unii":["SC7NUW5IIT"]},"product_type":"Drugs","event_id":"99330","recalling_firm":"Ascend Laboratories, LLC","address_1":"135 Us Highway 202 206 Ste 15","address_2":"N/A","postal_code":"07921-2608","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"USA Nationwide","recall_number":"D-0736-2026","product_description":"Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.","product_quantity":"2,717 cartons","reason_for_recall":"Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.","recall_initiation_date":"20260630","center_classification_date":"20260804","report_date":"20260729","code_info":"Lot: 25141584, Exp 4/30/2027."}]}}