Recalls / Class II
Class IID-0387-2026
Product
MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.
- Affected lot / code info
- Lot #: 795CP-0005, Exp. Date 06/30/2026
Why it was recalled
Stability Data Does Not Support Expiry Date.
Recalling firm
- Firm
- HTO Nevada Inc. dba Kirkman
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 6400 Rosewood St, N/A, Lake Oswego, Oregon 97035-5392
Distribution
- Quantity
- 243 bottles
- Distribution pattern
- Nationwide within the U.S
Timeline
- Recall initiated
- 2026-02-18
- FDA classified
- 2026-03-05
- Posted by FDA
- 2026-03-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0387-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.