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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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.

The Hazard

The presence of foreign tablets or capsules poses a significant health risk. Ingesting unidentified substances can lead to adverse reactions and complications.

Reported Incidents

No specific incidents of injury have been reported in connection with this recall. However, the potential for harm remains high due to the contamination.

What to Do

Stop using the recalled Trazodone Hydrochloride immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for further guidance.

Contact Information

For more information, consumers can visit the FDA recall page or contact Granules Pharmaceuticals Inc.

Key Facts

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

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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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