Revitaderm Wound Care — Class II drug recall D-0699-2026
Ongoing recall by Blaine Labs Inc, reported 2026-07-08, distributed nationwide. CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to b
| Recall number | D-0699-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Blaine Labs Inc, Santa Fe Springs, CA, United States |
| Recall initiated | 2026-04-08 |
| Classified | 2026-07-16 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 5,555 bottles |
| Reason classes | cgmp |
| NDC | 63347-0120, 63347-0120-01, 63347-0120-02 |
| Lot numbers | BL3435, BL3525 |
| Expiration dates | 2026-11-06, 2027-08-07 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0699-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.