Blaine Labs Inc recalls Revitaderm Wound Care
- Recalling company
- Blaine Labs Inc
- Product
- 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,
- Reason
- CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 8, 2026
- Reported
- Jul 8, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 5,555 bottles and tubes
- Lot / 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
- Company location
- Santa Fe Springs, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0699-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0699-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.