FDAClass IIIMay 15, 2024

Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule recall: Labeling Error

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,

Why was Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: 477-0016, Exp: 08/2025

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,
Recalling firm
HTO Nevada Inc DBA Kirkman
Quantity
366 bottles
Distribution
Distributed in CA, FL, OH, TX, WA and WI and in the following countries China, Netherlands, Pakistan, Peru, Switzerland, and United Kingdom.
Recall date
May 15, 2024
Classification
Class III
Status
Terminated
Agency
FDA (food)
Open FDA enforcement record Latest FDA food recalls