Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule dietary supplement, Folate 1667mcg DFE, 5000mcg Folic Acid, 120
Summary
The FDA issued a Class III for Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule dietary supplement, Fola by HTO Nevada Inc DBA Kirkman. Reason: Labeling error. The 5-MTHF 1mg label incorrectly declares 5000mcg Folic Acid instead 1000mcg Folic Acid per serving in the Supplement Facts, but corr.
Details
Source
Food Recall
External ID
F-1222-2024
Action Date
2024-05-15
Status
Terminated
Category
food
Product Description
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,
Lot/Code Info: Lot#: 477-0016, Exp: 08/2025
Quantity Affected: 366 bottles
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).
Distribution
Distributed in CA, FL, OH, TX, WA and WI and in the following countries China, Netherlands, Pakistan, Peru, Switzerland, and United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-12
Company
Lake Oswego, OR
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 32 food recalls issued in the same week, part of 204 food-related FDA actions this month.
HTO Nevada Inc DBA Kirkman has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (HTO Nevada Inc DBA Kirkman) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does HTO Nevada Inc DBA Kirkman have FDA actions?
HTO Nevada Inc DBA Kirkman has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1222-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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