Is this recall affecting only the Berry flavor?

The recall specifically lists CHILDERN NYQUIL COLD&FLU BERRY 8oz 12ct. Other flavors are not named in the recall notice.

Should I stop using this product immediately?

Yes. Consumers should stop using all affected lots and contact Gold Star Distribution Inc for guidance.

How do I know if my product is affected?

Check the packaging for lot and expiry details. The recall notice covers all lots within expiry distributed by Gold Star Distribution.

What should I do if my child has used the product and feels unwell?

Seek medical advice promptly and inform the clinician that the product was recalled.

Where can I find more information about the recall?

Refer to the FDA enforcement page using recall number D-0274-2026.

Will I receive a refund or replacement?

Remedy guidance indicates contact with the distributor for instructions. Refund or replacement processes are not detailed in the notice.

What is CGMP and why is this recall issued?

CGMP stands for Current Good Manufacturing Practice. The recall cites deviations indicating insanitary conditions at the distribution center.

Are there any reported injuries from this recall?

No injuries or illnesses are reported in connection with this recall.

How long will refunds or replacements take?

The notice does not specify, but recalls often take several weeks once initiated.

What should I do to prevent future issues when buying OTC medicines for kids?

Buy from reputable retailers, check packaging for lot and expiry dates, and monitor recall alerts from FDA and the product manufacturer.

HIGHDecember 26, 2025

Gold Star Distribution Recalls Children NyQuil Cold & Flu Berry 8oz 12ct (2026 Recall)

Gold Star Distribution recalls all lots of Children NyQuil Cold & Flu Berry 8oz 12ct sold nationwide in the United States. The recall cites CGMP deviations and insanitary conditions, including rodent exposure at the distributor's center. Consumers and healthcare providers should stop using this product immediately and contact Gold Star Distribution for guidance.

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

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

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.

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.

View Original Recall on FDA - Drug Safety

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

CHILDRENGENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › OTC Children's Cold & Flu Medicine

Product TypeLiquid Cough and Cold Syrup for Children

Product Details

Brand

Gold Star Distribution

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