CLASS II Food recall · Reported 11 Jul 2012 · FDA Enforcement Report
Xylishield Dental Care Kit containing of Cinnamon Xylishield gum recalled
Ultradent Products is recalling Xylishield Dental Care Kit containing of Cinnamon Xylishield gum, distributed nationwide in the US. The recall was initiated on 18 Jun 2012 and the FDA has classified it as Class II.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- F-1709-2012
- FDA event ID
- 62057
- Recalling firm
- Ultradent Products, South Jordan, UT
- Brand
- Xylishield Dental
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jun 2012
- FDA classified
- 2 Jul 2012
- Reported
- 11 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Undeclared Allergens
- Product category
- Ready Meals
Timeline
| 18 Jun 2012 | Recall initiated by company | |
| 2 Jul 2012 | Classified by FDA | +14 days |
| 11 Jul 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Food allergen labelling is required by US law for the nine major allergens. A product recalled for an undeclared allergen is only a risk to people with that allergy; everyone else can consume it safely.
Product as listed by the FDA
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.
Where it was distributed
Global distribution including USA (nationally), Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, Taiwan.
Questions about this recall
Why was it 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 omission of the major allergen Soy as a sub-ingredient in the ingredients statement.
Which lots are affected?
Lot numbers: 114033, B5P67, B5QT8, B5TLF, B5TX2, B5V43, B5W5F, B5XR5, B5Z1X, B66K3, B687V, B6CS2, B6NMP, B6SHW, B6VS9, B6XCG, B6Y9D, B71Q9.
Where was it sold?
Global distribution including USA (nationally), Albania, Bahrain, Bulgaria, Canada, Costa Rica, Georgia, India, Malaysia, Nepal, Paraguay, Syria, Taiwan.
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 62057This product is part of a recall event; the main page for the event is Cinnamon Xylishield xylitol gum recalled by Ultradent Products.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cinnamon Xylishield xylitol gum recalled by Ultradent ProductsCinnamon Xylishield | Ultradent Products | Undeclared Allergens | Nationwide | |
| CLASS II | Spearmint Xylishield xylitol gum recalled by Ultradent ProductsSpearmint Xylishield | Ultradent Products | Undeclared Allergens | Nationwide |
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