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Recall Observatory FDA recall evidence

Drug 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.

D-0387-2026

February 18, 2026

Class II

Product summary

Firm
HTO Nevada Inc. dba Kirkman
Event
Event 98494
Status
Ongoing
Classification
Class II
Quantity
243 bottles
Official record key
drug-enforcement:D-0387-2026

Official wording

Reason: Stability Data Does Not Support Expiry Date.

Code information: Lot #: 795CP-0005, Exp. Date 06/30/2026

Distribution pattern: Nationwide within the U.S

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Stability Data Does Not Support Expiry