Class I · Most seriousActive recall
Revitaderm Wound Care Gel
A reasonable chance it could cause serious harm or death.
Does this affect you?
Check your lot numberLot#: BL3608, Exp. 07/01/28.
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byBlaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670
| Distributed by / for | Blaine Labs Inc |
| NDC | 63347-120-02 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | Blaine Labs Inc |
| Distribution | Nationwide in the USA |
| Quantity | 1,171 - 1 oz bottles |
| Recall initiated | 2026-04-08 |
| Report date | 2026-07-08 |
| Recall completed | — |
| Recall number | D-0692-2026 |
| Classification | Class I |
| FDA status | Ongoing |
| Origin on file | Santa Fe Springs CA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.