Quick Facts at a Glance
- Recall Date
- December 26, 2025
- Hazard Level
- HIGH
- Brand
- Gold Star Distribution
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- CHILDREN, 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
- Gold Star Distribution
- Product type
- Liquid Cough and Cold Syrup for Children
- Model numbers
- All lots within expiry distributed by Gold Star Distribution.
- Sizes
- 8oz 12ct
- 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
This is a pediatric OTC liquid cough and cold medicine intended for children. It is used to relieve cold and flu symptoms in kids.
Why This Is Dangerous
CGMP deviations indicate insanitary conditions at the distribution center with rodent exposure, raising potential contamination risk to the product.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers may be exposed to contaminated product due to poor sanitary conditions at the distributor. No injuries have been reported yet.
Practical Guidance
How to identify if yours is affected
- Verify product name and packaging matches CHLIDREN NYQUIL COLD&FLU BERRY 8oz 12ct
- Check expiry date and lot code on the packaging
- Cross-check with FDA recall number D-0274-2026 on the enforcement page
Where to find product info
Lot numbers and expiry are on the product label. See FDA recall page for list of affected lots.
What timeline to expect
Refunds or replacements typically take 4-8 weeks after initiation.
If the manufacturer is unresponsive
- Document all contact attempts with Gold Star Distribution.
- Escalate to FDA recall contact channels if the company is slow to respond.
How to prevent similar issues
- When purchasing, verify lot numbers and expiry dates.
- Avoid products from distributors with sanitation concerns.
- Monitor recalls via FDA and manufacturer channels.
Documentation advice
Keep packaging, photos of the label, receipts, and all correspondence with the distributor.
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Product Details
Product name: CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct. Distributor: Gold Star Distribution. Distribution: US Nationwide. Sold since unspecified dates. Price: Not disclosed.
Key Facts
- All lots within expiry distributed by Gold Star Distribution.
- CGMP deviations and insanitary conditions at the distribution center.
- No injuries or illnesses reported in connection with this recall.
- Stop-use-recall guidance issued; follow distributor instructions for remedy.
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Safety Guide
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