{"recall":{"id":"fda-drug-99526","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Heritage Pharmaceuticals Inc recalls CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION","firm":"Heritage Pharmaceuticals Inc","date":"2026-07-30","reported":"2026-08-19","status":"Ongoing","classification":"Class II","products":[{"name":"CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51","code":"Lot #: 2411550, Exp. 2026/NOV.","quantity":"","number":"D-0768-2026","classification":"Class II"}],"reason":"Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide within the U.S","nationwide":true,"states":[],"units":"","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=99526","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"2a3aa76563e15b43","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=99526","record":[{"status":"Ongoing","city":"East Brunswick","state":"NJ","country":"United States","classification":"Class II","openfda":{"application_number":["ANDA207047"],"brand_name":["CLINDAMYCIN PALMITATE HYDROCHLORIDE"],"generic_name":["CLINDAMYCIN PALMITATE HYDROCHLORIDE"],"manufacturer_name":["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."],"product_ndc":["23155-603"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"substance_name":["CLINDAMYCIN PALMITATE HYDROCHLORIDE"],"rxcui":["562266"],"spl_id":["6b2e0bbb-397e-49b2-aaea-3ec3896b8beb"],"spl_set_id":["a2279019-9341-4346-8746-fea262b27dd8"],"package_ndc":["23155-603-51"],"is_original_packager":[true],"unii":["VN9A8JM7M7"]},"product_type":"Drugs","event_id":"99526","recalling_firm":"Heritage Pharmaceuticals Inc","address_1":"1 Tower Center Blvd Ste 1700","address_2":"","postal_code":"08816-1145","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the U.S","recall_number":"D-0768-2026","product_description":"CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51","product_quantity":"","reason_for_recall":"Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.","recall_initiation_date":"20260730","center_classification_date":"20260814","report_date":"20260819","code_info":"Lot #: 2411550, Exp. 2026/NOV.","more_code_info":""}]}}