MAXIMUM recall (HTO Nevada Inc. dba Kirkman)
DrugClass IIOngoing
Summary: HTO Nevada Inc. dba Kirkman is recalling MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.. Reason: Stability Data Does Not Support Expiry Date.
What is being recalled
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
Why
Stability Data Does Not Support Expiry Date.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the U.S
How to tell if yours is affected
Lot #: 807CP-0003, Exp. Date 07/31/2026.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0386-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 18, 2026 |
| Reported | March 11, 2026 |
| Company | HTO Nevada Inc. dba Kirkman |
| Company location | Lake Oswego, OR, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 178 bottles |
More recalls from HTO Nevada Inc. dba Kirkman · all drug recalls · recalls from February 2026