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Class III: unlikely to cause harmTerminated

HTO Nevada Inc DBA Kirkman Kirkman brand 5-MTHF Methyltetrahydrofolate Recall

Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule dietary supplement, Folate 1667…

HTO Nevada Inc DBA Kirkman · Lake Oswego, OR

Risk level
Class III
Reported by FDA
May 15, 2024
Recall ID
F-1222-2024
Check your lot numberHow we source this data

Summary

HTO Nevada Inc DBA Kirkman recalled Kirkman brand 5-MTHF Methyltetrahydrofolate starting Mar 12, 2024. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report F-1222-2024 on May 15, 2024. Reason: 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). Status: Terminated.

Why it was 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).

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 numbers, UPCs & expiration codes

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

Where it was sold

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

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-1222-2024
Classification
Class III
Status
Terminated
Recall initiated
Mar 12, 2024
FDA report date
May 15, 2024
Quantity
366 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
HTO Nevada Inc DBA Kirkman

Original FDA data

Every field from FDA enforcement report F-1222-2024, exactly as published.

Show all FDA fields
City
Lake Oswego
State
OR
Status
Terminated
Country
United States
Event ID
94230
Address
6400 Rosewood St
Code information
Lot#: 477-0016, Exp: 08/2025
Postal code
97035-5392
Report date
May 15, 2024
Product type
Food
Recall number
F-1222-2024
Classification
Class III
Recalling firm
HTO Nevada Inc DBA Kirkman
Product quantity
366 bottles
Termination date
Jun 25, 2024
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).
Voluntary / mandated
Voluntary: Firm initiated
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,
Distribution pattern
Distributed in CA, FL, OH, TX, WA and WI and in the following countries China, Netherlands, Pakistan, Peru, Switzerland, and United Kingdom.
Recall initiation date
Mar 12, 2024
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
May 8, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1222-2024, published May 15, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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