MODERATE RISK
Terminated
F-1708-2012
Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, white, and black with black, red and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8419.
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
17, 889 cartons
Product Type
Food
Code Info
Lot numbers: 112933, B5N16, B5PHZ, B5PZN, B5R5Y, B5TRB, B5VY1, B5WQQ, B5Z3J, B65QW, B68MW, B6CG1, B6GTW, B6HPK, B6K7Y, B6NKD, B6T39, B6XCN.
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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