Dietary supplement recalled for undeclared soy lecithin allergen
DesBio lunaSOMM Natural Sleep Support Dietary Supplement is recalled due to undeclared soy lecithin. The product is labeled as containing sunflower lecithin but contains soy lecithin, posing a risk to consumers with soy allergies.
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 a Class II recall involving undeclared soy lecithin, which is a common allergen. No illnesses or injuries have been reported. The severity reflects the risk posed to consumers with soy allergies who rely on accurate product labeling.
Plain-English summary
DesBio lunaSOMM Natural Sleep Support Dietary Supplement capsules are being recalled because the product contains undeclared soy lecithin. The supplement facts label declares Phosphatidylserine from non-GMO sunflower lecithin, but the product actually contains soy lecithin, which is not listed on the label.
The recall affects approximately 2547 bottles distributed nationwide in the United States, as well as to one distributor in Australia. The affected bottles are 30-count containers in blue PET bottles with white caps, with lot number 020323126 and a manufacturing date of April 2023.
Soy is a major food allergen. Undeclared allergens pose a significant health risk to individuals with soy allergies or sensitivities. Consumers who have purchased this product and have a soy allergy should stop using it immediately. Anyone who consumed the product and experiences symptoms should consult a healthcare provider.
The recalled product
- Product
- DesBio lunaSOMM Natural Sleep Support Dietary Supplement capsules, 30 count in a Blue PET bottle with a White cap. Supplement facts declare Phosphatidylserine (from non-GMO sunflower lecithin powder) 40 mg. Distributed by Deseret Biologicals Inc 469 West Parkland Dr, Sandy, UT.
- Manufacturer
- Deseret Biologicals Inc
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 2,547
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 020323126 MFG 04/2023
Distribution
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