FDA Recall D-0386-2026
HTO Nevada Inc. dba Kirkman · Lake Oswego, OR
Class II Ongoing 85 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
Reason for recall
Stability Data Does Not Support Expiry Date.
Recall record
- Recall number
D-0386-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide within the U.S
- Recall initiated
- 2026-02-18
- Classified by FDA Center
- 2026-03-05
- FDA published
- 2026-03-11
- Recalling firm
- HTO Nevada Inc. dba Kirkman
- Firm location
- Lake Oswego, OR
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.