Agency classClass IIOur severity:High FDA (Food)·F-1710-2012·Announced 2012-07-11

Ultradent Recalls Xylishield Gum for Missing Soy Allergen Labeling

Ultradent is recalling specific lots of Xylishield gum because the packaging failed to list soy as an ingredient. A separate lot of spearmint gum was also recalled due to accidental cinnamon flavoring.

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 the omission of a major allergen (soy) on common products, which meets the rubric criteria for a High severity score (3).

Plain-English summary

Ultradent Products, Inc. is recalling 36 lots of cinnamon-flavored Xylishield gum, sold in 60-piece cartons and dental care kits, because the ingredient statement omitted soy, a major allergen. Additionally, the company is recalling a single lot of spearmint-flavored gum that was accidentally manufactured with cinnamon-flavored product.

The recall covers 668 units of the spearmint gum, identified by lot number B6Y7B. The affected products were distributed globally, including in the United States, Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, and Taiwan.

Consumers with these products should stop using them and contact Ultradent for further instructions. The recall is classified as FDA Class II.

The recalled product

Product: Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is aqua, blue and white with black, aqua and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8418.
Manufacturer: Ultradent Products, Inc.
Category: Food — Chewing Gum
Hazard: allergen-soy
mis-labeling
Affected units: 668

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 numbers: B6Y7B.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Ultradent Products, Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Ultradent Products, Inc.

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