The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1466-2022·Announced 2022-09-07

Colgate Anticavity Fluoride Toothpaste recalled for improper storage conditions

Colgate Anticavity Fluoride Toothpaste, Optic White Renewal was recalled after being stored outside appropriate temperature conditions. The recall affects 840 packages distributed to Family Dollar stores in 11 states.

The agency’s classification

FDA (Drugs): 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II FDA recall with no reported illnesses or injuries. The hazard is precautionary, based on a storage compliance deviation rather than confirmed contamination or harm.

Plain-English summary

Colgate Anticavity Fluoride Toothpaste, Optic White Renewal (3% Hydrogen Peroxide formula, Net Weight 3.0 OZ / 85 g), UPC 0 35000 97008 4, is being recalled. The product was distributed by Colgate-Palmolive Company to Family Dollar retail stores in Arizona, California, Georgia, Idaho, Indiana, Montana, New Mexico, Nevada, Oregon, Texas, and Utah, affecting 840 packages.

The recall was initiated due to a cGMP deviation: the product was held outside of appropriate temperature storage conditions during distribution. This violates federal manufacturing standards for proper product storage and handling.

Consumers with questions about this recall can contact the U.S. Food and Drug Administration.

The recalled product

Product
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High Impact White, Net Wt. 3.0 OZ. (85 g) UPC 0 35000 97008 4. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Manufacturer
Family Dollar Stores, Llc.
Category
Drug — Oral Care
Hazard
Affected units
840

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 999088 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.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Family Dollar Stores, Llc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Family Dollar Stores, Llc.

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Same hazard · storage temperature deviation

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