Why it was recalled
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
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.
Lot numbers, UPCs & expiration codes
Lot#: BL3608, Exp. 07/01/28.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0692-2026
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Apr 8, 2026
- FDA report date
- Jul 8, 2026
- Quantity
- 1,171 - 1 oz bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Blaine Labs Inc
Original FDA data
Every field from FDA enforcement report D-0692-2026, exactly as published.
Show all FDA fields
- City
- Santa Fe Springs
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 98731
- Address
- 11037 Lockport Pl
- Code information
- Lot#: BL3608, Exp. 07/01/28.
- Postal code
- 90670-4634
- Report date
- Jul 8, 2026
- Product type
- Drugs
- Recall number
- D-0692-2026
- Classification
- Class I
- Recalling firm
- Blaine Labs Inc
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 8, 2026
- Initial firm notification
- Press Release
- Center classification date
- Jul 16, 2026