Maximum Zone2 Topical Analgesic (HTO Nevada) – Raw Material Issue (2023)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.dermalsource.com, 1-866-568-3223, NDC code: 80069-012-01, Drug Facts- For use by licensed professionals only' Active Ingredients- Lidocaine HCL (5%), Epinephrine (0.01%).
Brand
HTO Nevada, Inc.
Lot Codes / Batch Numbers
Lot #: 795CP-0003, Exp 07/2024.
Products Sold
Lot #: 795CP-0003, Exp 07/2024.
HTO Nevada, Inc. is recalling Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed due to cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026