The Recall Desk
HighFDA (Drugs)·D-0262-2026·Announced 2026-01-21

Aleve medication recalled nationwide due to insanitary distribution center conditions

Aleve 1's, 60 CT tablets are recalled nationwide because Gold Star Distribution's facility had insanitary conditions including rodent activity. Consumers should stop using the affected product and consult their healthcare provider.

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: FDA Class II recall with insanitary conditions and rodent activity in the distribution facility presents a risk of contamination to a medication. No illnesses or injuries have been reported, making this a theoretical risk rather than confirmed harm, which limits the score to 3 per the rubric.

Plain-English summary

Aleve 1's, 60 CT tablets distributed nationwide are being recalled due to Current Good Manufacturing Practice (CGMP) deviations at Gold Star Distribution Inc's distribution center. The facility had insanitary conditions, including evidence of rodent exposure and activity.

All lots of Aleve 1's, 60 CT that were within expiration date and distributed by Gold Star Distribution are included in this recall. The product was distributed to consumers nationwide.

Consumers who have this product should stop using it immediately. If you have questions or experience any health concerns, contact your healthcare provider or the FDA's MedWatch program.

The recalled product

Product
Aleve 1's, 60 CT
Manufacturer
GOLD STAR DISTRIBUTION INC
Category
Drug
Hazard
  • contamination
  • insanitary-conditions

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 (1)

  • All lots within expiry distributed by Gold Star Distribution.

Distribution

Distributed nationwide across the United States.

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