Ultradent Recalls Cinnamon Xylishield Gum Due to Missing Soy Allergen Labeling
Ultradent is recalling 36 lots of cinnamon Xylishield gum because the ingredients label failed to list soy, a major allergen.
What this means for you
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 allergen mislabeling on a common allergen (soy), which corresponds to a severity score of 3 (High) according to the rubric.
Plain-English summary
Ultradent Products, Inc. is recalling 36 lots of cinnamon-flavored Xylishield gum. The gum is sold in cartons containing 60 individual 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 packaged in blue and white packaging with black and white print writing and is advertised as a defense against cavities. The specific part number is 8405. The recall covers 4,083 units distributed globally, including the United States, Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, and Taiwan.
Consumers with soy allergies should avoid using the product. The affected lot numbers are 114033, B5P67, B5QT8, B5TLF, B5TX2, B5V43, B5W5F, B5XR5, B5Z1X, B66K3, B687V, B6CS2, B6NMP, B6SHW, B6VS9, B6XCG, B6Y9D, and B71Q9.
The recalled product
- Product
- 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.
- Manufacturer
- Ultradent Products, Inc.
- Category
- Food — Chewing Gum
- Hazard
- Affected units
- 4,083
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: 114033
- B5P67
- B5QT8
- B5TLF
- B5TX2
- B5V43
- B5W5F
- B5XR5
- B5Z1X
- B66K3
- B687V
- B6CS2
- B6NMP
- B6SHW
- B6VS9
- B6XCG
- B6Y9D
- B71Q9.
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.
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