NewChapter Probiotic Elderberry Recalled for Undeclared Soy Allergen
New Chapter, Inc. is recalling 1,004 bottles of Probiotic Elderberry dietary supplements because they may contain undeclared soy.
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: "The product may contain an undeclared allergen soy"
Plain-English summary
New Chapter, Inc. is voluntarily recalling 1,004 bottles of NewChapter Probiotic Elderberry, 90 vegetarian capsules. The recall is due to the potential presence of an undeclared allergen, soy.
The affected product is identified by Lot 01230049332 and an expiration date of 01/31/15. The lot number and expiration date are located on the bottom of the box and on the side of the bottle. The product was distributed in 35 states and the District of Columbia.
Consumers with soy allergies should not consume the product. Individuals with questions about the recall should contact New Chapter, Inc.
The recalled product
- Product
- NewChapter Probiotic Elderberry, 90 vegetarian capsules bottle. Dietary Supplement UPC: 7-27783-00123-8
- Manufacturer
- New Chapter, Inc.
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 1,004
Distribution
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