MODERATE RISK Terminated F-1709-2012

Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. The product is packaged in blue and white packaging with black and white print writing. The product is advertised as a defense against cavities. Part number 8405.

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.

Product Details

Product Quantity

4,083 units

Product Type

Food

Code Info

Lot numbers: 114033, B5P67, B5QT8, B5TLF, B5TX2, B5V43, B5W5F, B5XR5, B5Z1X, B66K3, B687V, B6CS2, B6NMP, B6SHW, B6VS9, B6XCG, B6Y9D, B71Q9.

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 28, 2026

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