{"recall":{"id":"fda-drug-99321","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"JB Chemicals and Pharmaceuticals Ltd recalls Cetirizine Hydrochloride Tablets USP 5 mg","firm":"JB Chemicals and Pharmaceuticals Ltd","date":"2026-06-24","reported":"2026-07-29","status":"Ongoing","classification":"Class I","products":[{"name":"Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.","code":"Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT","quantity":"34,020 100-count bottles.","number":"D-0732-2026","classification":"Class I"}],"reason":"Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Nationwide in the USA","nationwide":true,"states":[],"units":"34,020 100-count bottles.","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=99321","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e4f736a584ab5b44","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=99321","record":[{"status":"Ongoing","city":"Mumbai","state":"N/A","country":"India","classification":"Class I","openfda":{"application_number":["ANDA077829"],"brand_name":["CETIRIZINE HYDROCHLORIDE"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"manufacturer_name":["Rising Pharma Holdings, Inc."],"product_ndc":["16571-401"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"rxcui":["1014676"],"spl_id":["37fb3dd8-d5bf-46e4-8331-0c8c1eac540d"],"spl_set_id":["6493d4f6-dead-45ec-ade1-28ce624af33d"],"package_ndc":["16571-401-10"],"is_original_packager":[true],"unii":["64O047KTOA"]},"product_type":"Drugs","event_id":"99321","recalling_firm":"JB Chemicals and Pharmaceuticals Ltd","address_1":"Neelam Centre A Wing A B Wing","address_2":"4th Floor; Hind Cycle Road","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide in the USA","recall_number":"D-0732-2026","product_description":"Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.","product_quantity":"34,020 100-count bottles.","reason_for_recall":"Cross Contamination with Other Products: Customer complaints for appearance of  discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.","recall_initiation_date":"20260624","center_classification_date":"20260803","report_date":"20260729","code_info":"Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT"}]}}