The Recall Desk
HighFDA (Drugs)·D-1465-2022·Announced 2022-09-07

Colgate OPTIC WHITE PRO Series Toothpaste Recalled for Improper Storage

Family Dollar Stores is recalling 1,120 packages of Colgate OPTIC WHITE PRO SERIES toothpaste due to improper temperature storage conditions that deviate from cGMP standards.

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: This is an FDA Class II recall, which indicates potential for serious adverse health consequences from product stored outside appropriate temperature conditions. No illnesses or injuries have been reported. Per the rubric, identified risk-of-harm without yet-reported injury scores at most 3.

Plain-English summary

Colgate OPTIC WHITE PRO SERIES Anticavity Fluoride Toothpaste (5% Hydrogen Peroxide, Net Weight 2.1 oz/59g, UPC 0-35000-99658-9) distributed by Colgate-Palmolive Company is being recalled. The product was sold at Family Dollar retail stores.

The recall was initiated because the product was held outside of appropriate temperature storage conditions, which violates cGMP (Current Good Manufacturing Practice) requirements. The recall affects 1,120 packages with SKU 998277.

The recalled product was distributed nationwide to Family Dollar stores in Arizona, California, Georgia, Idaho, Indiana, Montana, New Mexico, Nevada, Oregon, Texas, and Utah.

Consumers who purchased this product should stop using it and return it to the store where it was purchased.

The recalled product

Product
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 35000 99658 9. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Manufacturer
Family Dollar Stores, Llc.
Hazard
  • improper-storage
  • gmp-deviation

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 (11)

  • SKUs 998277 distributed to Family Dollar retail stores in AZ
  • CA
  • GA
  • ID
  • IN
  • MT
  • NM
  • NV
  • OR
  • TX
  • UT

Distribution

Distributed nationwide across the United States.