The Recall Desk
HighFDA (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.

What this means for you

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.
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 →