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
- 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
- Claritin
- Model numbers
- All lots within expiry distributed by Gold Star Distribution.
- 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
January 28, 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
Claritin is an antihistamine used to relieve allergy symptoms such as sneezing, runny nose, and itchy eyes. Many consumers purchase it for seasonal allergies or year-round allergy relief.
Why This Is Dangerous
The presence of rodents in the distribution center raises concerns about contamination, which can lead to adverse health effects if ingested. Consumers may unknowingly expose themselves to harmful pathogens associated with rodent activity.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face health risks if they have used this product. The inconvenience of returning the product and seeking alternatives can also affect daily routines.
Practical Guidance
How to identify if yours is affected
- Check the UPC code on your product for 655708016305.
- Review any purchase receipts for the recalled product.
- Contact the retailer where you purchased the product for confirmation.
Where to find product info
UPC codes are usually located on the bottom or back of the product packaging. Look for the barcode that begins with 655708.
What timeline to expect
Expect a refund processing timeframe of approximately 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Document all communication attempts with the company.
- Reach out to the retailer for assistance in resolving the issue.
- Contact consumer protection agencies if further action is needed.
How to prevent similar issues
- Always check for recalls before purchasing over-the-counter medications.
- Inspect product packaging for signs of damage or contamination before use.
- Purchase medications from reputable sources to reduce the risk of contamination.
Documentation advice
Keep a copy of the purchase receipt and any correspondence with the manufacturer or retailer regarding the recall.
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Product Details
The recalled product is Claritin, 20 Count, with UPC 655708016305. It was distributed nationwide in the United States. The specific quantity of units recalled is unknown.
Key Facts
- Recall date: December 26, 2025
- Reported date: January 21, 2026
- Insanitary conditions due to rodent exposure
- Consumers advised to stop using the product
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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