MODERATE RISK Terminated F-1710-2012

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.

Recalled by Ultradent Products, Inc.

Classification

Class II — Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.

Reason for Recall

Ultradent is recalling 36 lots of cinnamon flavored Xylishield gum sold in cartons containing 60 individual pieces as well as within the Xylishield dental care kit due to the omission of the major allergen Soy as a sub-ingredient in the ingredients statement. They are also recalling a single lot of spearmint flavored gum as it was accidentally manufactured with cinnamon flavored product.

Product Details

Product Quantity
668 units
Product Type
Food
Code Info
Lot numbers: B6Y7B.
Voluntary/Mandated
Voluntary: Firm initiated

Distribution & Geography

Distribution Pattern
Global distribution including USA (nationally), Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, Taiwan.
Company Location
South Jordan, UT, 84095-3935

Timeline

Report Date
07/11/2012
Recall Initiated
06/18/2012
Classification Date
07/02/2012
Termination Date
01/09/2013

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: August 29, 2026

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