CLASS III Food recall · Reported 3 Apr 2013 · FDA Enforcement Report

Opalescence Treswhite Supreme Peach Patient Kit recalled

Ultradent Products is recalling Opalescence Treswhite Supreme Peach Patient Kit, distributed in 13 states. The recall was initiated on 8 Mar 2013 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot B6LZS, Part number 5705

Quantity recalled104 units

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-1271-2013
FDA event ID: 64534
Recalling firm: Ultradent Products, South Jordan, UT
Brand: Opalescence Treswhite
Classification: Class III
Status: Terminated
Recall initiated: 8 Mar 2013
FDA classified: 26 Mar 2013
Reported: 3 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Product category: Ready Meals

Timeline

8 Mar 2013	Recall initiated by company
26 Mar 2013	Classified by FDA	+18 days
3 Apr 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Opalescence Treswhite Supreme Peach Patient Kit

Where it was distributed

USA: AL, CA, GA, IL, IN, MA, MD, MI, NJ, OK, PA, SC, UT; 12 International distributors: Germany, China, France, Spain

Alabama California Georgia Illinois Indiana Massachusetts Maryland Michigan New Jersey Oklahoma Pennsylvania South Carolina Utah

Questions about this recall

Why was it recalled?

Product was packaged into kits labeled as having a shelf life of 2103-05. The correct shelf life is 2013-05.

Which lots are affected?

Lot B6LZS, Part number 5705

Where was it sold?

USA: AL, CA, GA, IL, IN, MA, MD, MI, NJ, OK, PA, SC, UT; 12 International distributors: Germany, China, France, Spain

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

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