Spermidine Dietary Supplement Recalled for Undeclared Wheat Allergen
Supplement Manufacturing Partner Inc. is recalling Spermidine Maximum Strength 10 mg dietary supplement (Lot 12792402-44) because it contains undeclared wheat, a major allergen not listed on the label.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Undeclared allergen: Wheat"
Plain-English summary
Supplement Manufacturing Partner Inc. is recalling Spermidine, Maximum Strength, 10 mg per serving dietary supplement because the product contains wheat that is not declared on the product label. The recalled product is packaged in 120-count PETE plastic bottles with white lids.
Consumers with wheat allergies who consume this product may experience allergic reactions. The affected lot is 12792402-44, distributed throughout the United States and Germany.
Consumers who have purchased this product should stop using it. If you have any of the recalled product and have a wheat allergy, consult a healthcare provider if you have experienced an allergic reaction after using it.
The recalled product
- Product
- Spermidine, Maximum Strength, 10 mg per serving, Support healthy Aging, Dietary Supplement, 120 Capsules, oral consumption, shelf life: 24 months, PETE/White/150cc Plastic bottle/lid, 120 count.Supplement Facts: Spermidine 3HCL 10mg*** Other Ingredients: Hydroxypropyl…
- Manufacturer
- Supplement Manufacturing Partner Inc.
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 6,465
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 12792402-44
Distribution
Distribution scope not specified by the agency.
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