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High risk Drugs & MedicationsClass II

Tylenol Multiple Products Recall

TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT

Updated December 26, 2025

Several Tylenol products are being recalled due to insanitary conditions, including rodent exposure and activity, at the distribution center. Exposure to rodent contamination poses a serious health risk.

Is the GOLD STAR DISTRIBUTION INC recalled? Yes. This product was recalled by FDA on December 26, 2025. Details below.

What is recalled

Tylenol products distributed by Gold Star Distribution Inc: (a) 500 mg, 2's Display, 50 count; (b) Cold & Flu, 25 count/2 pack; (c) Cold & Flu Severe, 2 pack, 50 count; (d) PM, 50 count; and (e) Sinus Severe, 2 pack, 50 count.

Am I affected

You're affected if you purchased any Tylenol product from Gold Star Distribution Inc in these formats: 500 mg 2's Display 50 count, Cold & Flu 25 count/2 pack, Cold & Flu Severe 2 pack 50 count, PM 50 count, or Sinus Severe 2 pack 50 count.

What to do right now

Stop using these Tylenol products immediately. Contact the seller or Gold Star Distribution Inc for a refund or replacement. Do not use any of the recalled products.

The hazard

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

Brands affected

GOLD STAR DISTRIBUTION INC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0277-2026
Classification
Class II
Recalled
December 26, 2025
Read the official notice

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