HIGH

Tylenol Recall by Gold Star Distribution Affects 5 SKUs in 2026

Gold Star Distribution is recalling Tylenol products distributed nationwide. The recall concerns CGMP deviations and insanitary conditions at the distributor’s facility. Consumers should stop using these Tylenol products 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
Unknown
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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

About This Product

Over‑the‑counter analgesic Tylenol products used for pain relief and cold/flu symptoms. Widely distributed in the U.S.

Why This Is Dangerous

CGMP deviations and insanitary conditions in the distribution center raise contamination concerns for products in the supply chain.

Industry Context

This recall is not stated as part of a broader industry pattern.

Real-World Impact

Consumers should stop using affected Tylenol products immediately. The recall emphasizes safety checks at distribution centers and follow‑up communications for refunds or replacements.

Practical Guidance

How to identify if yours is affected

  1. Identify Tylenol products manufactured for distribution by Gold Star Distribution.
  2. Check five recalled SKUs listed in the notice.
  3. Inspect expiry and lot numbers on packaging.

Where to find product info

FDA recall page and Gold Star Distribution notices for additional details.

What timeline to expect

Refunds or replacements typically issued within weeks following submission of claim.

If the manufacturer is unresponsive

  • File a consumer complaint with the CPSC if needed.
  • Maintain records of all communications.
  • Seek legal advice if the company is unresponsive for an extended period.

How to prevent similar issues

  • Buy Tylenol from reputable retailers.
  • Inspect packaging and vendor information before purchase.
  • Stay updated on recall notices from FDA and the distributor.

Documentation advice

Keep packaging, purchase receipts, photos of product labels, and all recall communications.

Product Details

Brand: Tylenol. Distributor: Gold Star Distribution. Product family: OTC analgesics. SKUs recalled: 5 Tylenol products listed in the recall. Distribution: US nationwide. Lots: All lots within expiry distributed by Gold Star Distribution. Sold at: Nationwide distribution. Price: Unknown.

Key Facts

  • 5 Tylenol SKUs recalled
  • All lots within expiry distributed by Gold Star Distribution
  • No consumer injuries reported
  • Stop use immediately
  • Contact Gold Star Distribution for guidance
View Original Recall on FDA - Drug Safety

Browse More Recalls

More from FDA_DRUGHealth & Personal CareDrugs & Medications

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

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

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

Product Classification

Product TypeAcetaminophen Tablets
Sold At
Unknown

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

Related Recalls

Health & Personal Care
HIGH

GOLD STAR DISTRIBUTION Vaporizing Chest Rub Recall 2026 All Lots Nationwide

Gold Star Distribution is recalling all lots of its Vaporizing Chest Rub, 4 oz, 12-count, UPC 048155903319, distributed nationwide in the United States. The recall, number D-0283-2026, stems from CGMP deviations including insanitary conditions with rodent exposure/activity at the distribution center. Consumers and healthcare providers should stop using the product immediately and contact Gold Star

Gold Star Distribution
CGMP Deviations:
Read more
Health & Personal Care
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.

NyQuil
CGMP Deviations:
Read more
Health & Personal Care
HIGH

Gold Star Distribution's Halls Cough Drops Recall 2026 Over Rodent-Linked CGMP Violations

Gold Star Distribution is recalling all Halls cough drops distributed nationwide. The recall covers multiple SKUs including Menthol 12-count bags and Vitamin C 20-count lozenges. The root cause cited is CGMP deviations with insanitary conditions and rodent exposure at the distribution center. Consumers should stop using these products and follow recall instructions from Gold Star Distribution.

Gold Star Distribution
CGMP Deviations:
Read more
Health & Personal Care
HIGH

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.

Gold Star Distribution
CGMP Deviations:
Read more
Health & Personal Care
HIGH

Lucky Ice Cool Mouthwash Recall 2026 After CGMP Deviations at Gold Star Distribution

Lucky Ice Cool Mouthwash is being recalled nationwide in the United States. The action targets all lots distributed by Gold Star Distribution due to CGMP deviations and insanitary conditions, including rodent exposure in the distribution center. Consumers should stop using the product immediately and contact Gold Star Distribution for guidance.

Lucky Ice
CGMP Deviations:
Read more
Health & Personal Care
HIGH

Aleve 60-Count Pain Relievers Recalled for CGMP Deviations by Gold Star Distribution (2026)

Gold Star Distribution recalls Aleve 60-count pain relievers distributed nationwide due to CGMP deviations and insanitary conditions at its distribution center. Rodent exposure and activity were reported at the facility. Consumers and healthcare providers should stop using the product immediately and contact Gold Star Distribution for guidance.

Aleve
CGMP Deviations:
Read more
Health & Personal Care
HIGH

Gold Star Distribution Ice Gel 8oz 12-Count Recalled for CGMP Violations (2026)

Gold Star Distribution recalls 8oz Ice Gel 12-count sold nationwide after investigators found insanitary conditions at the distributor's facility. A CGMP deviation allowed rodent exposure at the distribution center. Consumers and healthcare providers should stop using this product immediately and await guidance from Gold Star Distribution.

Gold Star Distribution
CGMP Deviations:
Read more
Health & Personal Care
HIGH

Gold Star Distribution Recalls Liquid DayQuil 12/8oz for CGMP Issues (2025)

Gold Star Distribution is recalling Liquid DayQuil 12/8oz distributed nationwide in the United States. The recall cites CGMP deviations and insanitary conditions, including rodent exposure at the distribution center. Consumers and healthcare providers should stop using the product immediately and contact Gold Star Distribution for guidance.

Gold Star Distribution
CGMP Deviations:
Read more