Multivitamin supplement recalled for undeclared drugs and aspartame
Armonia Natural Store LLC is recalling OneMultivitaminic GAF-PLUS Advance 300ml for containing undeclared Acetaminophen, Dexamethasone Phosphate, and Aspartame. Consumers should discontinue use immediately.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for undeclared pharmaceutical drugs in a dietary supplement product. No illnesses or injuries are reported in the source. The product represents a risk-of-harm scenario—consumers may unknowingly consume drugs that could interact with other medications—without reported injury, fitting the Score 3 criterion: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Armonia Natural Store LLC is recalling OneMultivitaminic GAF-PLUS Advance 300ml multivitamin supplement due to the presence of undeclared pharmaceutical ingredients. The affected product is supplied in plastic bottles with lot number 000297-0060724, expiration date 07/2026, and comprises 64 bottles total.
The product contains three undeclared ingredients not disclosed on the label: the drugs Acetaminophen and Dexamethasone Phosphate, and the sweetener Aspartame. Consumers purchasing this product are unaware they are consuming pharmaceutical drugs, which poses a health risk particularly if combined with other medications or for individuals sensitive to aspartame.
The affected product was distributed across twelve U.S. states: Florida, Georgia, North Carolina, South Carolina, Rhode Island, New York, New Jersey, Virginia, Nebraska, Illinois, California, and Wisconsin.
Consumers who have purchased this product should discontinue use immediately and contact Armonia Natural Store LLC for instructions on return or proper disposal.
The recalled product
- Product
- OneMultivitaminic GAF-PLUS Advance 300ml, plastic bottle, Room Temperature
- Manufacturer
- Armonia Natural Store LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 64
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 (1)
- Lot# 000297-0060724 Expiration Date:07/2026
Distribution
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