Dietary Supplement Labeling Error: Kirkman 5-MTHF Folic Acid Misdeclared
Kirkman 5-MTHF dietary supplement has a labeling error: the Supplement Facts incorrectly states 5000mcg Folic Acid per serving instead of 1000mcg. Lot# 477-0016, exp. 08/2025.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III labeling error. The Supplement Facts panel incorrectly states 5000mcg Folic Acid per serving instead of 1000mcg, though the actual product and front label are correct. Per the severity rubric, minor labeling errors are scored as Moderate (2).
Plain-English summary
Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule dietary supplement (UPC 8 12325 02354 7, 120 capsules per package) is subject to a labeling correction. The Supplement Facts panel incorrectly declares 5000mcg Folic Acid per serving instead of 1000mcg Folic Acid per serving. The front label correctly identifies the product as 5-MTHF Methyltetrahydrofolate 1mg, and the Folate 1667mcg DFE statement is accurate.
Affected bottles carry Lot# 477-0016 with expiration date 08/2025. Approximately 366 bottles were distributed in California, Florida, Ohio, Texas, Washington, and Wisconsin, as well as internationally to China, Netherlands, Pakistan, Peru, Switzerland, and the United Kingdom.
The product is manufactured by HTO Nevada Inc DBA Kirkman in Lake Oswego, Oregon. The FDA classified this as a Class III recall (F-1222-2024).
The recalled product
- 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,
- Manufacturer
- HTO Nevada Inc DBA Kirkman
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 366
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: 477-0016
- Exp: 08/2025
Distribution
Related recalls
Same manufacturer · HTO Nevada Inc DBA Kirkman
See all →- ModerateVasocaine lidocaine spray recalled because stability data does not support expiry
FDA (Drugs) · 2026-03-11
- ModerateZone 2 lidocaine cream recalled because stability data does not support expiry
FDA (Drugs) · 2026-03-11
- ModerateZone 1 lidocaine cream recalled because stability data does not support expiry
FDA (Drugs) · 2026-03-11
Same hazard · mislabeling
See all →- ModerateOrthofix MINIRAIL External Fixation Devices Incorrectly Labeled
FDA (Devices) · 2026-07-22
- ModerateWise Onion Rings recalled for undeclared food color additives
FDA (Food) · 2026-07-15
- HighBakr Brown Butter Chocolate Chunk Cookie Dough Recalled for Undeclared Soy
FDA (Food) · 2026-07-15
- HighStapes prosthesis pistons carry an incorrect functional length on labeling
FDA (Devices) · 2026-06-10
- HighMedline eye trays contain insulin syringes labeled as tuberculin syringes
FDA (Devices) · 2026-06-03
Similar recalls
- LowNature's Blend Folic Acid Recalled for Labeling Error
FDA (Food) · 2020-04-08
- ModerateNutri-Dyn Recalls 5-HTP Extra Strength Capsules Due to Mislabeling
FDA (Food) · 2015-04-15
- ModerateBluebonnet Methylfolate Chewables Recalled for Label Unit Error
FDA (Food) · 2024-04-03
- ModerateEclectic Herb Vitamin Blend Dietary Supplement Recalled for Label Errors
FDA (Food) · 2025-01-22
- LowHealthmaxx Global Recalls MAX Nitric Oxide Enhance Due to Mislabeling
FDA (Food) · 2013-10-02
- ModerateHealthmaxx Recalls Stem Cell Enhance Supplements Due to Mislabeling
FDA (Food) · 2013-10-02