Why it was recalled
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
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,
Lot numbers, UPCs & expiration codes
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
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-0699-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 8, 2026
- FDA report date
- Jul 8, 2026
- Quantity
- 5,555 bottles and tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Blaine Labs Inc
Original FDA data
Every field from FDA enforcement report D-0699-2026, 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
- 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
- Postal code
- 90670-4634
- Report date
- Jul 8, 2026
- Product type
- Drugs
- Recall number
- D-0699-2026
- Classification
- Class II
- Recalling firm
- Blaine Labs Inc
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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,
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 8, 2026
- Initial firm notification
- Press Release
- Center classification date
- Jul 16, 2026