Why it was recalled
Stability Data Does Not Support Expiry Date.
Product description
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
Lot numbers, UPCs & expiration codes
Lot #: 807CP-0003, Exp. Date 07/31/2026.
Where it was sold
Nationwide within the U.S
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0386-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 18, 2026
- FDA report date
- Mar 11, 2026
- Quantity
- 178 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- HTO Nevada Inc. dba Kirkman
Original FDA data
Every field from FDA enforcement report D-0386-2026, exactly as published.
Show all FDA fields
- City
- Lake Oswego
- State
- OR
- Status
- Ongoing
- Country
- United States
- Event ID
- 98494
- Address
- 6400 Rosewood St
- Code information
- Lot #: 807CP-0003, Exp. Date 07/31/2026.
- Postal code
- 97035-5392
- Report date
- Mar 11, 2026
- Product type
- Drugs
- Recall number
- D-0386-2026
- Classification
- Class II
- Recalling firm
- HTO Nevada Inc. dba Kirkman
- Product quantity
- 178 bottles
- Reason for recall
- Stability Data Does Not Support Expiry Date.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
- Distribution pattern
- Nationwide within the U.S
- Recall initiation date
- Feb 18, 2026
- Initial firm notification
- Center classification date
- Mar 5, 2026