Moderate riskFDA DrugClass II

Aleve 1's, 60 CT recalled for rodent exposure at distributor

Gold Star Distribution Inc. distributed Aleve 1's (60-count bottles) that were stored in conditions that did not meet safety standards. The distribution center had insanitary conditions and evidence of rodent activity. All unexpired lots distributed by this company are affected.

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

What to do

  1. Stop using Aleve 1's purchased from Gold Star Distribution
  2. Check the package or receipt to see if your product came from this distributor
  3. Return the product to where you bought it or contact the manufacturer for guidance
  4. Contact your doctor or poison control (1-800-222-1222) if you have health concerns

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Aleve 1's, 60 CT
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-0262-2026

In the FDA's words

Description
Aleve 1's, 60 CT 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.

Related topics

OtherDrugsSold nationwideMore from FDA Drug