{"recall":{"id":"fda-drug-98731","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Blaine Labs Inc recalls 8 products","firm":"Blaine Labs Inc","date":"2026-04-08","reported":"2026-07-08","status":"Ongoing","classification":"Class I","products":[{"name":"Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02.","code":"Lot#: BL3608, Exp. 07/01/28.","quantity":"1,171 - 1 oz bottles","number":"D-0692-2026","classification":"Class I"},{"name":"TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01.","code":"Lot #: BL3435, Exp. 11/06/26","quantity":"519 - 1 oz bottles","number":"D-0693-2026","classification":"Class II"},{"name":"TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01.","code":"Lot #BL3411R, Exp 6/8/2027","quantity":"144 bottles","number":"D-0694-2026","classification":"Class II"},{"name":"TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01.","code":"Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027.","quantity":"22,143 bottles","number":"D-0695-2026","classification":"Class II"},{"name":"vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.","code":"Lot BL3462, Exp. 2/7/2027","quantity":"26,475 bottles","number":"D-0696-2026","classification":"Class II"},{"name":"TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01","code":"Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.","quantity":"5,801 bottles","number":"D-0697-2026","classification":"Class II"},{"name":"Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid). Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670, Manufactured for Doctor's Inc","code":"Lot BL3572, Exp 04/16/2028","quantity":"1,500 bottles","number":"D-0698-2026","classification":"Class II"},{"name":"Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,","code":"Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27","quantity":"5,555 bottles and tubes","number":"D-0699-2026","classification":"Class II"}],"reason":"Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated","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":"1,171 - 1 oz bottles; 519 - 1 oz bottles; 144 bottles; 22,143 bottles; 26,475 bottles; 5,801 bottles; 1,500 bottles; 5,555 bottles and tubes","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=98731","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"61f5c74d225bf558","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=98731","record":[{"status":"Ongoing","city":"Santa Fe Springs","state":"CA","country":"United States","classification":"Class I","openfda":{},"product_type":"Drugs","event_id":"98731","recalling_firm":"Blaine Labs Inc","address_1":"11037 Lockport Pl","address_2":"N/A","postal_code":"90670-4634","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide in the USA","recall_number":"D-0692-2026","product_description":"Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02.","product_quantity":"1,171 - 1 oz bottles","reason_for_recall":"Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp","recall_initiation_date":"20260408","center_classification_date":"20260716","report_date":"20260708","code_info":"Lot#: BL3608, Exp. 07/01/28."},{"status":"Ongoing","city":"Santa Fe Springs","state":"CA","country":"United States","classification":"Class II","openfda":{"application_number":["M003"],"brand_name":["TRIDERGEL"],"generic_name":["BENZALKONIUM CHLORIDE"],"manufacturer_name":["Trifluent Pharma LLC"],"product_ndc":["73352-520"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"substance_name":["BENZALKONIUM CHLORIDE"],"rxcui":["1049228","2671305"],"spl_id":["baebaab7-5c13-426e-bcfb-4fdedb4885b4"],"spl_set_id":["f12d9e8c-1d69-49d9-a9e9-a392c681aa6c"],"package_ndc":["73352-520-01"],"is_original_packager":[true],"unii":["F5UM2KM3W7"]},"product_type":"Drugs","event_id":"98731","recalling_firm":"Blaine Labs Inc","address_1":"11037 Lockport Pl","address_2":"N/A","postal_code":"90670-4634","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide in the USA","recall_number":"D-0693-2026","product_description":"TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01.","product_quantity":"519 - 1 oz bottles","reason_for_recall":"CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated","recall_initiation_date":"20260408","center_classification_date":"20260716","report_date":"20260708","code_info":"Lot #: BL3435, Exp. 11/06/26"},{"status":"Ongoing","city":"Santa Fe Springs","state":"CA","country":"United States","classification":"Class II","openfda":{"application_number":["M005"],"brand_name":["TRIPENICOL S"],"generic_name":["UNDECYLENIC ACID"],"manufacturer_name":["Trifluent Pharma LLC"],"product_ndc":["73352-550"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"substance_name":["UNDECYLENIC ACID"],"rxcui":["998329","2677081"],"spl_id":["6a5dd16f-5fbd-4509-af06-5e2c248518e3"],"spl_set_id":["b57500e1-ea6f-4043-99d6-326a7eb57f2f"],"package_ndc":["73352-550-01"],"is_original_packager":[true],"unii":["K3D86KJ24N"]},"product_type":"Drugs","event_id":"98731","recalling_firm":"Blaine Labs Inc","address_1":"11037 Lockport Pl","address_2":"N/A","postal_code":"90670-4634","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide in the USA","recall_number":"D-0694-2026","product_description":"TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213,  NDC 73352-550-01.","product_quantity":"144 bottles","reason_for_recall":"CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry","recall_initiation_date":"20260408","center_classification_date":"20260716","report_date":"20260708","code_info":"Lot #BL3411R, Exp 6/8/2027"},{"status":"Ongoing","city":"Santa Fe Springs","state":"CA","country":"United States","classification":"Class II","openfda":{"application_number":["M005"],"brand_name":["TERPENICOL"],"generic_name":["UNDECYLENIC ACID"],"manufacturer_name":["Blaine Labs Inc."],"product_ndc":["63347-601"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"substance_name":["UNDECYLENIC ACID"],"spl_id":["f6a16024-2fa1-44ff-a718-af2dc7ae822e"],"spl_set_id":["efd99ed1-07d3-4862-ae47-883f7d1c91c6"],"package_ndc":["63347-601-01"],"is_original_packager":[true],"unii":["K3D86KJ24N"]},"product_type":"Drugs","event_id":"98731","recalling_firm":"Blaine Labs Inc","address_1":"11037 Lockport Pl","address_2":"N/A","postal_code":"90670-4634","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide in the USA","recall_number":"D-0695-2026","product_description":"TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01.","product_quantity":"22,143 bottles","reason_for_recall":"CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry","recall_initiation_date":"20260408","center_classification_date":"20260716","report_date":"20260708","code_info":"Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027."},{"status":"Ongoing","city":"Santa Fe Springs","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"98731","recalling_firm":"Blaine Labs Inc","address_1":"11037 Lockport Pl","address_2":"N/A","postal_code":"90670-4634","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide in the USA","recall_number":"D-0696-2026","product_description":"vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.","product_quantity":"26,475 bottles","reason_for_recall":"CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry","recall_initiation_date":"20260408","center_classification_date":"20260716","report_date":"20260708","code_info":"Lot BL3462, Exp. 2/7/2027"},{"status":"Ongoing","city":"Santa Fe Springs","state":"CA","country":"United States","classification":"Class II","openfda":{"application_number":["M005"],"brand_name":["TERPENICOL"],"generic_name":["UNDECYLENIC ACID"],"manufacturer_name":["Blaine Labs Inc."],"product_ndc":["63347-600"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"substance_name":["UNDECYLENIC ACID"],"rxcui":["998329","2745978"],"spl_id":["92f83cae-7224-46f8-a9ac-550118c21f29"],"spl_set_id":["a020334e-aac9-4ea5-a0ea-8e5b021fe2eb"],"package_ndc":["63347-600-01"],"is_original_packager":[true],"unii":["K3D86KJ24N"]},"product_type":"Drugs","event_id":"98731","recalling_firm":"Blaine Labs Inc","address_1":"11037 Lockport Pl","address_2":"N/A","postal_code":"90670-4634","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide in the USA","recall_number":"D-0697-2026","product_description":"TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01","product_quantity":"5,801 bottles","reason_for_recall":"CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry","recall_initiation_date":"20260408","center_classification_date":"20260716","report_date":"20260708","code_info":"Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027."},{"status":"Ongoing","city":"Santa Fe Springs","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Drugs","event_id":"98731","recalling_firm":"Blaine Labs Inc","address_1":"11037 Lockport Pl","address_2":"N/A","postal_code":"90670-4634","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide in the USA","recall_number":"D-0698-2026","product_description":"Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz  bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid).  Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670, Manufactured for Doctor's Inc","product_quantity":"1,500 bottles","reason_for_recall":"CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry","recall_initiation_date":"20260408","center_classification_date":"20260716","report_date":"20260708","code_info":"Lot BL3572, Exp 04/16/2028"},{"status":"Ongoing","city":"Santa Fe Springs","state":"CA","country":"United States","classification":"Class II","openfda":{"application_number":["M003"],"brand_name":["REVITADERM WOUND CARE"],"generic_name":["BENZALKONIUM CHLORIDE"],"manufacturer_name":["Blaine Labs Inc."],"product_ndc":["63347-120"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"substance_name":["BENZALKONIUM CHLORIDE"],"rxcui":["1049228","1310820"],"spl_id":["69b73949-a7e7-4e85-911e-ae688d658bbf"],"spl_set_id":["9254dada-4e32-43a0-892b-c488d68e23e7"],"package_ndc":["63347-120-01","63347-120-02"],"is_original_packager":[true],"unii":["F5UM2KM3W7"]},"product_type":"Drugs","event_id":"98731","recalling_firm":"Blaine Labs Inc","address_1":"11037 Lockport Pl","address_2":"N/A","postal_code":"90670-4634","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Press Release","distribution_pattern":"Nationwide in the USA","recall_number":"D-0699-2026","product_description":"Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,","product_quantity":"5,555 bottles and tubes","reason_for_recall":"CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated","recall_initiation_date":"20260408","center_classification_date":"20260716","report_date":"20260708","code_info":"Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27"}]}}