HIGH

Granules Pharmaceuticals Recalls Trazodone Hydrochloride Over Contamination Risk

Granules Pharmaceuticals Inc. recalled 71,424 bottles of Trazodone Hydrochloride on January 26, 2026. The recall stems from the presence of foreign tablets or capsules in the product. Consumers should stop using the medication immediately and consult their healthcare provider.

Quick Facts at a Glance

Recall Date
January 26, 2026
Hazard Level
HIGH
Brands
TRAZODONE HYDROCHLORIDE, Granules Pharmaceuticals Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Presence of Foreign Tablets/Capsules

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for guidance. Notification method: N/A

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About This Product

Trazodone Hydrochloride is an antidepressant used primarily to treat depression and anxiety disorders. Consumers typically buy it for its sedative effects to help with sleep and mood regulation.

Why This Is Dangerous

The contamination with foreign tablets or capsules poses significant health risks, as these unidentified substances may cause adverse effects or interact negatively with existing medications.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers face potential health risks from this recall, requiring immediate action to avoid possible complications.

Practical Guidance

How to identify if yours is affected

  1. Check the batch number on the bottle.
  2. Verify if it matches Batch # 6160008A.
  3. Look for the expiration date, which should be 12/31/2026.

Where to find product info

The batch number and expiration date can typically be found on the label or bottom of the bottle.

What timeline to expect

Realistically, expect 4-6 weeks for refund processing after returning the product.

If the manufacturer is unresponsive

  • Document all communications with the company.
  • Contact your healthcare provider for further assistance.
  • Report to the FDA if the company does not respond.

How to prevent similar issues

  • Always check for recalls before purchasing medications.
  • Look for signs of damage or tampering on packaging.
  • Consult a pharmacist about any concerns with medication quality.

Documentation advice

Keep a record of your purchase, including receipts and communication regarding the recall.

Product Details

The recall affects Trazodone Hydrochloride, USP, 50 mg, packaged in 100-count bottles. The affected batch number is 6160008A, with an expiration date of December 31, 2026. The product was distributed nationwide in the United States.

Key Facts

  • 71,424 bottles recalled
  • Batch number 6160008A
  • Expiration date 12/31/2026
  • Presence of foreign tablets/capsules
  • Stop using immediately

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
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Batch # 6160008A
Exp Date: 12/31/2026
UPC Codes
70010-231
70010-232
70010-233
+11 more
Affected States
ALL
Report Date
February 11, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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