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.
What this means for you
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
- mislabeling
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
Distributed in 6 states:
- CA
- FL
- OH
- TX
- WA
- WI
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27