FDAFDA recall D-0699-2026 · Jul 8, 2026
Blaine Labs Inc: Revitaderm Wound Care recall
Recall found
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 for recall
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- Quantity
- 5,555 bottles and tubes
- Distribution
- Nationwide in the USA
- Recalling firm
- Blaine Labs Inc, Santa Fe Springs, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-04-08
Source: openFDA enforcement record D-0699-2026 · search recall number D-0699-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.