5-MTHF Methylfolate Capsules (Kirkman) – Labeling Error (2024)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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,
Brand
HTO Nevada Inc DBA Kirkman
Lot Codes / Batch Numbers
Lot#: 477-0016, Exp: 08/2025
Products Sold
Lot#: 477-0016, Exp: 08/2025
HTO Nevada Inc DBA Kirkman is recalling Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule dietary supplement, Folate 1667mcg DFE, 5000 due to Labeling error. The 5-MTHF 1mg label incorrectly declares 5000mcg Folic Acid instead 1000mcg Folic Acid per serving in the Supplement Facts, but corr. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IN, OH, TX, WA, WI
Page updated: Jan 6, 2026