Lake Oswego, OR, United States
HTO Nevada Inc. dba Kirkman recalls
2 recalls recorded since 2018, most recently on 18 February 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 18 February 2026
- Reason
- Stability Data Does Not Support Expiry Date.
- Distribution
- Nationwide within the U.S
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0385-2026, D-0387-2026, D-0386-2026
- FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
- 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.
- MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
Terminated Class III Food
- Recall started
- 12 March 2024
- Terminated
- 25 June 2024
- Reason
- Labeling error. The 5-MTHF 1mg label incorrectly declares 5000mcg Folic Acid instead 1000mcg Folic Acid per serving in the Supplement Facts, but correctly declares Folate 1667mcg DFE. The front label correctly declares product as 5-MTHF Methyltetrahydrofolate 1mg (or 1000mcg).
- Distribution
- Distributed in CA, FL, OH, TX, WA and WI and in the following countries China, Netherlands, Pakistan, Peru, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- F-1222-2024
- Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule dietary supplement, Folate 1667mcg DFE, 5000mcg Folic Acid, 120 capsules per package, UPC 8 12325 02354 7. Manufactured exclusively by: Kirkman, Lake Oswego, OR 970
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.