{"recall":{"id":"fda-drug-99733","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Ajanta Pharma USA Inc recalls Fluphenazine Hydrochloride Tablets","firm":"Ajanta Pharma USA Inc","date":"2026-08-25","reported":"2026-09-16","status":"Ongoing","classification":"Class III","products":[{"name":"Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.","code":"Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.","quantity":"403,200 tablets","number":"D-0836-2026","classification":"Class III"}],"reason":"Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.","hazard":"FDA Class III: not likely to cause adverse health consequences (FDA definition).","affected":"Nationwide within the U.S","nationwide":true,"states":[],"units":"403,200 tablets","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=99733","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"f8fdbeeff8aafdd0","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=99733","record":[{"status":"Ongoing","city":"Bridgewater","state":"NJ","country":"United States","classification":"Class III","openfda":{"application_number":["ANDA217410"],"brand_name":["FLUPHENAZINE HYDROCHLORIDE"],"generic_name":["FLUPHENAZINE HYDROCHLORIDE"],"manufacturer_name":["Ajanta Pharma USA Inc."],"product_ndc":["27241-252","27241-255","27241-254","27241-253"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["FLUPHENAZINE HYDROCHLORIDE"],"rxcui":["859841","860918","865117","865123"],"spl_id":["0069bda4-a743-4edd-a15f-a53cba1a2bff"],"spl_set_id":["47695e20-9c0b-4a6b-ab1a-1dfaa75e96d8"],"package_ndc":["27241-255-01","27241-254-01","27241-253-01","27241-252-01"],"is_original_packager":[true],"upc":["0327241255014","0327241252013","0327241253010","0327241254017"],"unii":["ZOU145W1XL"]},"product_type":"Drugs","event_id":"99733","recalling_firm":"Ajanta Pharma USA Inc","address_1":"400 Crossing Blvd Ste 102","address_2":"","postal_code":"08807-2863","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0836-2026","product_description":"Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only,  Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.","product_quantity":"403,200 tablets","reason_for_recall":"Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.","recall_initiation_date":"20260825","center_classification_date":"20260908","report_date":"20260916","code_info":"Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.","more_code_info":""}]}}