Agency classClass IIOur severity:High FDA (Food)·F-1708-2012·Announced 2012-07-11

Ultradent Recalls Cinnamon Xylishield Gum Due to Missing Soy Allergen Labeling

Ultradent is recalling 36 lots of Cinnamon Xylishield gum because the packaging fails to list soy as an ingredient. The gum was distributed globally.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 mislabeling of a common allergen (soy), which corresponds to the 'High' severity criterion in the rubric.

Plain-English summary

Ultradent Products, Inc. is recalling 36 lots of Cinnamon Xylishield xylitol gum. The product is sold in cartons containing 60 pieces and is also included in the Xylishield dental care kit. The recall is due to the omission of the major allergen soy as a sub-ingredient in the ingredients statement.

The affected product is part number 8419, with a net weight of 84 g. The packaging is red, white, and black with black, red, and white print. The gum is advertised for use in fighting against tooth decay. The specific lot numbers involved are 112933, B5N16, B5PHZ, B5PZN, B5R5Y, B5TRB, B5VY1, B5WQQ, B5Z3J, B65QW, B68MW, B6CG1, B6GTW, B6HPK, B6K7Y, B6NKD, B6T39, and B6XCN.

The recall covers 17,889 cartons. Distribution was global, including the United States (nationally), Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, and Taiwan. Consumers should check their lot numbers against the list provided and stop using the product if it matches.

The recalled product

Product: 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.
Manufacturer: Ultradent Products, Inc.
Category: Food — Chewing Gum
Hazard: allergen-soy
mis-labeling

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 (18)

Lot numbers: 112933
B5N16
B5PHZ
B5PZN
B5R5Y
B5TRB
B5VY1
B5WQQ
B5Z3J
B65QW
B68MW
B6CG1
B6GTW
B6HPK
B6K7Y
B6NKD
B6T39
B6XCN.

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 →

Same manufacturer · Ultradent Products, Inc.

See all →

High
Jiffy composite polisher cups may crumble and break apart easily
FDA (Devices) · 2026-04-08
High
Dental Composite Resin Recall Due to Red Particulate Contamination
FDA (Devices) · 2024-09-18
High
FDA Recalls Transcend Dental Composite Material Due to Manufacturing Defect
FDA (Devices) · 2024-09-18
Moderate
Ultradent Recalls Vit-l-escence Composite Due to Red Particulates
FDA (Devices) · 2024-09-18
High
Dental bonding primer may lack resin component affecting restoration
FDA (Devices) · 2022-07-20

Same hazard · allergen soy