Assist and Amend Digestive Enzyme Formula Dietary Supplement Recall—Undeclared Allergens
New Dawn Nutrition is recalling Assist and Amend Advanced Digestive Enzyme Formula (Lot #361551, Best By 2022) because it contains undeclared milk, wheat, and soy. Consumers with allergies to these substances are at risk of allergic reaction.
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: The recall involves allergen mislabeling of common allergens (milk, wheat, soy). Although no illnesses or injuries have been reported in the source text, undeclared allergens on dietary supplements pose a direct risk of harm to consumers with allergies to these substances, meeting the High severity threshold per the rubric.
Plain-English summary
New Dawn Nutrition, Inc. is recalling Assist and Amend Advanced Digestive Enzyme Formula, a dietary supplement sold in 60-capsule bottles. The product was distributed to two retail consumers in the Omaha area. Lot #361551 with a Best By date of 2022 is affected by this recall.
The recall was issued because the product contains undeclared milk, wheat, and soy. These are common allergens that may not be disclosed on the label or packaging. Consumers with allergies or sensitivities to milk, wheat, or soy who purchased this product may experience allergic reactions if they consume it.
Consumers who have purchased this product should stop using it immediately if they have a known allergy or sensitivity to milk, wheat, or soy. Those with questions about whether they purchased a recalled product should contact New Dawn Nutrition, Inc. or the FDA.
The recalled product
- Product
- Assist and Amend Advanced Digestive Enzyme Formula, Dietary Supplement, 60 capsules per bottle, Manufactured for and distributed by New Dawn Nutrition Omaha, NE
- Manufacturer
- New Dawn Nutrition, Inc.
- Category
- Food — Dietary Supplement
- Affected units
- 4
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 #361551 Best By 2022
Distribution
Distribution scope not specified by the agency.
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