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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About This Product

NyQuil Cold & Flu is a household OTC medication used to relieve cold and flu symptoms. The 32-count, 2-pack format is common for households and travelers.

Why This Is Dangerous

CGMP deviations indicate insanitary conditions at the distribution center, including rodent exposure. This raises concerns about product hygiene and potential contamination risk.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers face a potential safety risk due to unsanitary distribution conditions. There is no reported injury data in the recall notice, but action is advised.

Practical Guidance

How to identify if yours is affected

  1. Verify NyQuil Cold & Flu 32-count 2-pack packaging matches the recall description
  2. Check distributor: Gold Star Distribution
  3. Confirm expiry dates and that the product is within expiry
  4. Review recall notice for lot information on the container
  5. Do not consume if you have the product in your home

Where to find product info

FDA enforcement report D-0273-2026 and recall notice linked in FDA database

What timeline to expect

Not specified in the recall notice; typical recall processing varies by distributor and regulatory guidance

If the manufacturer is unresponsive

  • Document all contact attempts
  • Escalate to FDA Consumer Hotline or state attorney general if no response after multiple attempts
  • Consider seeking legal advice if you experience harm or the distributor is unresponsive

How to prevent similar issues

  • Buy from reputable retailers
  • Check packaging for tampering
  • Verify CGMP compliance when possible
  • Keep recall notices for reference

Documentation advice

Keep the recall notice, product packaging, purchase records, and notes of all communications with the distributor or healthcare provider

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.

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
View Original Recall on FDA - Drug Safety

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Safety Guide

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Safety Assessment

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

Product Classification

Product TypeOTC Cold & Flu Medication
Sold At
Multiple Retailers

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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