CLASS II Drug recall · Reported 22 Feb 2023 · FDA Enforcement Report
Maximum Zone2 Topical Analgesic recalled by HTO Nevada
HTO Nevada is recalling Maximum Zone2 Topical Analgesic, for use during a pain sensitive procedure, distributed nationwide in the US. The recall was initiated on 9 Feb 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0271-2023
- FDA event ID
- 91694
- Recalling firm
- HTO Nevada, Lake Oswego, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Feb 2023
- FDA classified
- 15 Feb 2023
- Reported
- 22 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 9 Feb 2023 | Recall initiated by company | |
| 15 Feb 2023 | Classified by FDA | +6 days |
| 22 Feb 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Product as listed by the FDA
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%).
Where it was distributed
Nationwide in the USA and Canada.
Questions about this recall
Is Maximum Zone2 Topical Analgesic, for use during a pain sensitive procedure recalled?
Yes. HTO Nevada recalled Maximum Zone2 Topical Analgesic, for use during a pain sensitive procedure on 9 Feb 2023. The recall is Class II and its status is Terminated. Recall number D-0271-2023.
Why was it recalled?
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Which lots are affected?
Lot #: 795CP-0003, Exp 07/2024.
Where was it sold?
Nationwide in the USA and Canada.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Maximum, Zone 1, 4% Lidocaine Cream recalled by HTO Nevada | HTO Nevada | Potency & Assay | Nationwide |
| Drug | CLASS II | Maximum, Zone 2, 4% Lidocaine Cream, (Lidocaine recalled by HTO Nevada | HTO Nevada | Potency & Assay | Nationwide |
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