{"recall":{"id":"fda-drug-99421","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Ascend Laboratories, LLC recalls 3 products","firm":"Ascend Laboratories, LLC","date":"2026-07-16","reported":"2026-08-05","status":"Ongoing","classification":"Class III","products":[{"name":"Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.","code":"Lot: 25141583, Exp. April 30, 2027.","quantity":"3,600 cartons x 6 x 10 (in blister pack)","number":"D-0737-2026","classification":"Class III"},{"name":"Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.","code":"Lot: 25141585, Exp. April 30, 2027.","quantity":"924 cartons x 12 x 6 x 10 (in blister pack)","number":"D-0738-2026","classification":"Class III"},{"name":"Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.","code":"Lot: 25141586, Exp. April 30, 2027.","quantity":"936 cartons x 12 x 3 x 10 (in blister pack)","number":"D-0739-2026","classification":"Class III"}],"reason":"Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability","hazard":"FDA Class III: not likely to cause adverse health consequences (FDA definition).","affected":"USA Nationwide","nationwide":true,"states":[],"units":"3,600 cartons x 6 x 10 (in blister pack); 924 cartons x 12 x 6 x 10 (in blister pack); 936 cartons x 12 x 3 x 10 (in blister pack)","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=99421","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"4b8fd9cb4184c560","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=99421","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":"99421","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-0737-2026","product_description":"Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.","product_quantity":"3,600 cartons x 6 x 10 (in blister pack)","reason_for_recall":"Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability","recall_initiation_date":"20260716","center_classification_date":"20260805","report_date":"20260805","code_info":"Lot: 25141583, Exp. April 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":"99421","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-0738-2026","product_description":"Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.","product_quantity":"924 cartons x 12 x 6 x 10 (in blister pack)","reason_for_recall":"Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability","recall_initiation_date":"20260716","center_classification_date":"20260805","report_date":"20260805","code_info":"Lot: 25141585, Exp. April 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":"99421","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-0739-2026","product_description":"Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.","product_quantity":"936 cartons x 12 x 3 x 10 (in blister pack)","reason_for_recall":"Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability","recall_initiation_date":"20260716","center_classification_date":"20260805","report_date":"20260805","code_info":"Lot: 25141586, Exp. April 30, 2027."}]}}