Maximum Zone2 Topical Analgesic — Class II drug recall D-0271-2023
Terminated recall by HTO Nevada, Inc., reported 2023-02-22, distributed nationwide. cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
| Recall number | D-0271-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | HTO Nevada, Inc., Lake Oswego, OR, United States |
| Recall initiated | 2023-02-09 |
| Classified | 2023-02-15 |
| Reported by FDA | 2023-02-22 |
| Terminated | 2023-11-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,571 bottles |
| Reason classes | cgmp |
| NDC | 80069-0012-01 |
| Lot numbers | 795CP-0003 |
| Expiration dates | 2024-07 |
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%).
Reason for recall
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0271-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.