Blaine Labs Inc recall records

8 reported ongoing

10 records in this archive. Latest source date Apr 8, 2026. 1 published notices do not supply a closure status.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA drug enforcement

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 ...

Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp

Class IReported ongoing

Distribution: Nationwide in the USA

Official source for Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shor...
FDA drug enforcement

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, ...

CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source for TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bot...
FDA drug enforcement

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...

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source for TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manu...
FDA drug enforcement

Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antif...

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source for Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Funga...
FDA drug enforcement

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) tu...

CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

Class IIReported ongoing

Distribution: Nationwide in the USA

Official source for Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 ...
FDA drug enforcement

REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL...

Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.

Class IReported terminated

Distribution: Nationwide in 17 States to 45 doctors.

Official source for REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-...

Reasons in these listed records

  • 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

These examples come from this result page and are not a ranking of every recall reason.

Checking Blaine Labs Inc

Is there a recall on blaine labs inc right now?

This archive contains 10 records, including 8 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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