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Recall Observatory FDA recall evidence

Food 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,

F-1222-2024

March 12, 2024

Class III

Product summary

Firm
HTO Nevada Inc DBA Kirkman
Event
Event 94230
Status
Terminated
Classification
Class III
Quantity
366 bottles
Official record key
food-enforcement:F-1222-2024

Official wording

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).

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

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling error