Reported Feb 11, 2026 · Ongoing

Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500…

Granules Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Granules Pharmaceuticals Inc. · 3701 Concorde Pkwy · Chantilly, VA · 20151-1126

Is this the product you have?

  • Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only
  • Manufactured byGranules India Limited, Hyderabad, 500 081, India
  • Manufactured forGranules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01
Lot codes and dates
  • Batch # 6160008A
  • Exp Date12/31/2026
Amount recalled
71424 bottles.

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign Tablets/Capsules

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:06 PM UTC

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