Recall archive / FDA company announcement
Revitaderm, Tridergel: Antiseptic wound care gel bottles and tubes — FDA announcement Apr 8, 2026
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Apr 8, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Antiseptic wound care gel bottles and tubes
- Reason
- Products were found to contain Lysinibacillus fusiformis, an environmental organism
- Classification
- Not supplied
- Recalling firm
- Blaine Labs, Inc.
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 2dc24375caad83ef
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Santa Fe Springs, California – April 07, 2026 – Blaine Labs, Inc. is voluntarily recalling three (3) lot numbers of Wound Care Gel products, 1 oz. & 3 oz. (0.1% Benzalkonium Chloride) to the consumer level due to microbial contamination.; The product is used as a topical antiseptic for first aid to help prevent the risk of infection in minor cuts, scrapes, and burns and is packaged in a 1 oz. bottle and 3 oz. tube. The Revitaderm® Wound Care Gel can be identified by its purple trim and Tridergel™ Wound Care can be identified by its light blue trim. The 1 oz. bottle has two cap configurations, twist and longer pointy cap, and is secured with a shrink / body band. The bottle has the expiration date and lot number printed on the bottom portion of the bottle. The 3 oz. is a tube and contains the lot number and expiration date imprinted along the crimp at the top of the tube. Revitaderm® Wound Care Antiseptic Gel 1 oz. & 3 oz. and Tridergel™ Wound Care 1 oz. was distributed nationwide in the U.S to healthcare providers (doctor’s offices) they were not distributed for retail or internet sales.; Lot Number/EXP Date/Packaging: BL3608, 07/01/28 Printed with Yellow ink on the bottom of the bottle (1 oz.), shorter twist cap.; Lot Number/EXP Date/Packaging: BL3435, 11/06/26 Printed with Black ink on the bottom of the bottle (1 oz.), long pointy cap; Lot Number/EXP Date/Packaging: BL3435, 11/06/26 Imprinted on the tube crimp (3 oz.); Lot Number/EXP Date/Packaging: BL3525, 08/07/27 Printed with Black ink on the bottom of the bottle (1 oz.), long pointy cap; Lot Number/EXP Date/Packaging: BL3525, 08/07/27 Imprinted on the tube crimp (3 oz.); Customers & Healthcare providers should review their inventory for these affected lot number and discontinue use and / or distribution immediately. Immediately stop using the product. Segregate any remaining inventory of these lot numbers and please contact Blaine Labs, Inc to arrange for return.; Blaine Labs, Inc. is notifying its physician clinics by regular mail and by phone, as applicable, and is arranging for the return of undispensed 1 oz. and 3 oz. from lot numbers associated with this recall. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Apr 8, 2026
- Company announcement date
- Apr 8, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.