CLASS III Food recall · Reported 15 May 2024 · FDA Enforcement Report

Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule recalled

HTO Nevada is recalling Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule dietary supplement, Folate, distributed in California, Florida, Ohio, Texas, Washington, Wisconsin. The recall was initiated on 12 Mar 2024 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot#: 477-0016, Exp: 08/2025
Quantity recalled366 bottles

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

Recall details

Recall number
F-1222-2024
FDA event ID
94230
Recalling firm
HTO Nevada, Lake Oswego, OR
Brand
Kirkman
Classification
Class III
Status
Terminated
Recall initiated
12 Mar 2024
FDA classified
8 May 2024
Reported
15 May 2024
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Labeling Errors
Product category
Vitamins

Timeline

12 Mar 2024Recall initiated by company
8 May 2024Classified by FDA+57 days
15 May 2024Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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).

Product as listed by the FDA

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,

Where it was distributed

Distributed in CA, FL, OH, TX, WA and WI and in the following countries China, Netherlands, Pakistan, Peru, Switzerland, and United Kingdom.

CaliforniaFloridaOhioTexasWashingtonWisconsin

Questions about this recall

Why was it 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).

Which lots are affected?

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

Where was it sold?

Distributed in CA, FL, OH, TX, WA and WI and in the following countries China, Netherlands, Pakistan, Peru, Switzerland, and United Kingdom.

What should I do if I have it?

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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