Recall · openFDA Food Enforcement

Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule…: FDA Recall F-1222-2024

Agency action: Mar 12, 2024Record ID: F-1222-2024
View official source ↗

What happened

Original notice title

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…

From the archived source record

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).

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

Read the official notice →

Status and source details

Status recorded in the archive
Terminated
FDA recall classification
Class III
Recall initiated by
Voluntary: Firm initiated
Report date
May 15, 2024
Termination date in the archive
Jun 25, 2024
Source checked
Jul 16, 2026
Record revision
79005bf6962b

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

Product
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 9703,
Company
HTO Nevada Inc DBA Kirkman
Lot / identifier
Lot#: 477-0016, Exp: 08/2025
Market / distribution
Distributed in CA, FL, OH, TX, WA and WI and in the following countries China, Netherlands, Pakistan, Peru, Switzerland, and United Kingdom.