Revitaderm Wound Care Gel — Class I drug recall D-0692-2026
Ongoing recall by Blaine Labs Inc, reported 2026-07-08, distributed nationwide. Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis a
| Recall number | D-0692-2026 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| 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 | 1,171 |
| Reason classes | microbial contamination, sterility |
| NDC | 63347-0120-02 |
| Lot numbers | BL3608 |
| Expiration dates | 2028-07-01 |
Product
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.
Reason for recall
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
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-0692-2026. 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.