Blaine Labs Inc drug recall: Revitaderm Wound Care Gel
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I, Class II
- Status
- Ongoing
- Event ID
- 98731
- Recall initiated
- Apr 8, 2026
- Classified by FDA
- Jul 16, 2026
- Posted in Enforcement Report
- Jul 8, 2026
- Recalling firm
- Blaine Labs Inc
- Firm location
- Santa Fe Springs, CA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Press Release
- Products in this event
- 8
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
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
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
- Class II: Using or being exposed to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
About this recall
The firm started this recall on Apr 8, 2026. FDA classified it 99 days later, on Jul 16, 2026. This recall event covers 8 separate products, each with its own FDA recall number. Distribution reported by FDA: Nationwide in the USA Blaine Labs Inc has 2 recalls in our records.
Recalled products (8)
D-0692-2026 Class I Ongoing
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.
Codes / lots: Lot#: BL3608, Exp. 07/01/28.
Quantity: 1,171 - 1 oz bottles
D-0693-2026 Class II Ongoing
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.
Codes / lots: Lot #: BL3435, Exp. 11/06/26
Quantity: 519 - 1 oz bottles
D-0694-2026 Class II Ongoing
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.
Codes / lots: Lot #BL3411R, Exp 6/8/2027
Quantity: 144 bottles
D-0695-2026 Class II Ongoing
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.
Codes / lots: Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027.
Quantity: 22,143 bottles
D-0696-2026 Class II Ongoing
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.
Codes / lots: Lot BL3462, Exp. 2/7/2027
Quantity: 26,475 bottles
D-0697-2026 Class II Ongoing
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
Codes / lots: Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.
Quantity: 5,801 bottles
D-0698-2026 Class II Ongoing
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
Codes / lots: Lot BL3572, Exp 04/16/2028
Quantity: 1,500 bottles
D-0699-2026 Class II Ongoing
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,
Codes / lots: 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
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 98731
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.