HIGH

NyQuil Cold & Flu 32-Count 2-Pack Recalled for CGMP Violations (2026)

NyQuil Cold & Flu 32-count 2-pack is being recalled by Gold Star Distribution in the United States. The recall cites CGMP deviations and insanitary conditions at the distribution center, including rodent exposure. Stop using the product and contact the distributor for guidance.

Quick Facts at a Glance

Recall Date
December 26, 2025
Hazard Level
HIGH
Brands
NyQuil, Gold Star Distribution
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact GOLD STAR DISTRIBUTION INC or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Product Details

Product: NyQuil Cold & Flu 32-count, 2-pack. Distributor: Gold Star Distribution Inc. Distributed nationwide in the US. Recall date: 2025-12-26. Status: Active. Hazard: CGMP deviations with insanitary conditions, including rodent exposure at the distribution center. Remedy: Stop using immediately; contact Gold Star Distribution Inc or your healthcare provider for guidance.

The Hazard

CGMP deviations indicate insanitary conditions at the distribution center. Rodent exposure and activity are cited as part of the hazard.

What to Do

1. Stop using the product. 2. Contact Gold Star Distribution or your healthcare provider for guidance. 3. Monitor for updates from the recall notice or FDA communications. 4. Follow recall notification methods if you are contacted by the distributor (email, fax, letter, press release, telephone, or in person). 5. Do not consume the product until advised otherwise.

Contact Information

The notice cites Gold Star Distribution Inc as the distributor. Specific phone numbers, websites, or hours are not provided in the text of the recall notice.

Key Facts

  • NyQuil Cold & Flu 32-count, 2-pack
  • Distributor: Gold Star Distribution Inc
  • Nationwide distribution in the US
  • Recall date: 2025-12-26
  • Status: Active as of 2026-01-21

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
All lots within expiry distributed by Gold Star Distribution.
Affected States
ALL
Report Date
January 21, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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