FDA·Medicines·February 11, 2026

Granules recalls trazodone 50 mg tablets over foreign tablets or capsules found in bottles

The notice says some bottles of trazodone hydrochloride 50 mg tablets, 100 count, may contain foreign tablets or capsules, meaning pills that do not belong in the bottle.

What to do

The notice does not give instructions. Read the official notice for details.

Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.

Recall details

Product
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.
Hazard
Presence of Foreign Tablets/Capsules
Units
71424 bottles.
Where sold
US Nationwide.
FDA classification
Class II · Ongoing
Classified by FDA
February 11, 2026
Recall started
January 26, 2026
FDA enforcement report
February 11, 2026
Identifiers
  • Codes: Batch # 6160008A, Exp Date: 12/31/2026
  • FDA recall number: D-0305-2026

The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.

Official notice

The notice's own wording from FDA.

Product
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.
Reason for recall
Presence of Foreign Tablets/Capsules
Classification
Class II (Ongoing)
Distribution
US Nationwide.
Quantity
71424 bottles.

Related recalls