Recall Weekly
Moderate riskFDA DrugClass II

Tylenol cold, flu, PM and sinus products recalled for rodent exposure

Several Tylenol products distributed by Gold Star Distribution Inc. were stored in conditions where rodents were present at their distribution center. This poses a potential contamination risk. The recall affects multiple Tylenol formulations including 500 mg, Cold & Flu, Cold & Flu Severe, PM, and Sinus Severe products nationwide.

From the FDA notice · Read the official notice ↗ · All Gold Star Distribution recalls

What to do

  1. Check your medicine cabinet for affected Tylenol products distributed by Gold Star Distribution
  2. Do not use any recalled products
  3. Return them to the pharmacy or place of purchase for a refund or replacement
  4. Contact the FDA or your pharmacist if you have questions about whether your product is affected
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 27 products — see all of them.

Details

Illnesses reported
None reported
Manufactured in
1000 Humboldt Ave N, Minneapolis, MN, United States
Classification
Class II
Recall number
D-0277-2026

In the FDA's words

Description
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 CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. All lots within expiry distributed by Gold Star Distribution. Distribution: US Nationwide.
Hazard
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

27 products in this recall

Advil, Tylenol and more OTC medicines recalled for rodent exposure

Gold Star Distribution is recalling 27 over-the-counter products, including pain relievers, cold and flu medicines, antacids, cough drops, skin and lip care, petroleum jelly, rubbing alcohol and mouthwash. The products were stored or distributed from a facility with insanitary conditions, including rodent exposure and activity. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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