The Recall Desk
HighFDA (Devices)·Z-1084-2026·Announced 2026-01-21

Lucky Ice mouthwash recalled over insanitary conditions at a distribution center

Gold Star Distribution is recalling Lucky Ice Cool Mouthwash over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.

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: Scored 3 under the risk-of-harm criterion: the record cites insanitary conditions with rodent activity affecting distributed product, and no illnesses are reported.

Plain-English summary

Lucky Ice Cool Mouthwash, alcohol free, 16.9oz, 12 count, UPC 808829108989, distributed by Gold Star Distribution Inc, is being recalled.

The reason given in the enforcement record is CGMP deviations: insanitary conditions including rodent exposure and activity in the firm's distribution center.

The recall covers all lots within expiry distributed by Gold Star Distribution. The record does not state a quantity. Distribution was nationwide in the US. The FDA has classified the action as Class II.

Consumers who have this product should not use it and should follow the retailer's return instructions.

The recalled product

Product
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.
Manufacturer
Diagnostica Stago, Inc.
Category
Drug — Oral care
Hazard
  • insanitary-conditions
  • rodent-activity
  • cgmp-deviation

Distribution

Distributed nationwide across the United States.

Related recalls

Same category