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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- NyQuil, Gold Star Distribution
- Product type
- OTC Cold & Flu Medication
- Model numbers
- All lots within expiry distributed by Gold Star Distribution.
- Sizes
- 32-count 2-pack
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 26, 2025
Reported by FDA DRUG
January 21, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Verify NyQuil Cold & Flu 32-count 2-pack packaging matches the recall description
- Check distributor: Gold Star Distribution
- Confirm expiry dates and that the product is within expiry
- Review recall notice for lot information on the container
- 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
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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.
Key Facts
- NyQuil Cold & Flu 32-count, 2-pack
- Distributor: Gold Star Distribution Inc
- Nationwide distribution in the US
- Status: Active as of 2026-01-21
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Safety Guide
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