Class IITerminated in FDA datasetRecall initiated Jun 18, 2012

Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60…

Recalling firm: Ultradent Products, Inc.

Why it was recalled

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…

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Jan 9, 2013.

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ProductSpearmint 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.
Package size84 g

FDA code information

Lot numbers: B6Y7B.

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Full FDA record and distribution details

Original product description

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.

Original FDA recall reason

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.

Recall details

Recall number
F-1710-2012
Event ID
62057
FDA status
Terminated
Initiated
Jun 18, 2012
Reported
Jul 11, 2012
Classified
Jul 2, 2012
Terminated
Jan 9, 2013
Quantity
668 units
Location
South Jordan, UT, United States
Initiation type
Voluntary: Firm initiated
Notification
Letter

Where it was distributed

Global distribution including USA (nationally), Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, Taiwan.

FDA source record · F-1710-2012

Data updated September 16, 2026. View official FDA data ↗

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