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

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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

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

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Safety Assessment

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

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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