{"recall":{"id":"fda-drug-99278","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Bell Pharmaceuticals, Inc recalls 11 products","firm":"Bell Pharmaceuticals, Inc","date":"2026-06-25","reported":"2026-07-22","status":"Ongoing","classification":"Class II","products":[{"name":"CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,","code":"Lot: a) 1505121, 1504242, exp 2027-03; 1505132, 1505182, 1505191, 1505291, 1505331, exp 2027-04; b) 1504231, 1504311, exp 2027-03; 1505312, 1505321, exp 2027-04.","quantity":"106,301 units","number":"D-0678-2026","classification":"Class II"},{"name":"Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. 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MO 63005.","code":"Lot: a)1505123, expires: 2027-04; b) 1505131, expires: 2027-04.","quantity":"5,762 units","number":"D-0682-2026","classification":"Class II"},{"name":"FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.","code":"Lot: 1505124, 1505311, 1505332, expires: 2027-04.","quantity":"11, 977 units","number":"D-0683-2026","classification":"Class II"},{"name":"GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.","code":"Lot: a) 1505334, expires: 2027-04; b) 1505143, 1505151, expires: 2027-04","quantity":"20, 160 units","number":"D-0684-2026","classification":"Class II"},{"name":"LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.","code":"Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.","quantity":"5, 471 units","number":"D-0685-2026","classification":"Class II"},{"name":"Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.","code":"Lot:1505161, 1505181, 1505301, 1505382, exp 2027-04.","quantity":"31,094 units","number":"D-0686-2026","classification":"Class II"},{"name":"meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.","code":"Lot:1505344, exp 2027-04.","quantity":"993 units","number":"D-0687-2026","classification":"Class II"},{"name":"CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.","code":"Lot:1505141, exp 2027-04.","quantity":"1,201 units","number":"D-0688-2026","classification":"Class II"}],"reason":"SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S Nationwide","nationwide":true,"states":[],"units":"106,301 units; 29, 474 units; 15, 843 units; 16,156 units; 5,762 units; 11, 977 units; 20, 160 units; 5, 471 units; 31,094 units; 993 units; 1,201 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=99278","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c2dd9c9361080a5f","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=99278","record":[{"status":"Ongoing","city":"Belle Plaine","state":"MN","country":"United States","classification":"Class II","openfda":{"application_number":["M014"],"brand_name":["CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AID","CVS HEALTH EARWAX REMOVAL KIT"],"generic_name":["CARBAMIDE PEROXIDE"],"manufacturer_name":["CVS Pharmacy, Inc."],"product_ndc":["51316-822","51316-823"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"substance_name":["CARBAMIDE PEROXIDE"],"rxcui":["702050"],"spl_id":["1ba4260c-f726-77de-e063-6294a90ab529","52f5c6f4-95ea-d093-e063-6394a90a037c"],"spl_set_id":["42a22e06-1b66-4359-852c-7c39e1b3940a","f842534c-46dd-42c7-8386-9a03ce16da86"],"package_ndc":["51316-822-00","51316-823-00"],"is_original_packager":[true],"unii":["31PZ2VAU81"],"upc":["0050428078273"]},"product_type":"Drugs","event_id":"99278","recalling_firm":"Bell Pharmaceuticals, Inc","address_1":"200 W Beaver St","address_2":"","postal_code":"56011-1894","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S Nationwide","recall_number":"D-0678-2026","product_description":"CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. 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