Moderate riskFDA DrugClass II

Granules trazodone 50 mg tablets recalled for foreign tablets

Granules Pharmaceuticals is recalling certain bottles of trazodone 50 mg because some bottles may contain foreign tablets or capsules mixed in. This affects 71,424 bottles with batch number 6160008A and an expiration date of 12/31/2026. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have trazodone from Granules Pharmaceuticals with batch #6160008A
  2. If you do, stop taking it and contact your pharmacist or doctor
  3. Do not flush medications; ask your pharmacist how to safely dispose of them
  4. Call your pharmacy or doctor if you have questions about your prescription

Is yours affected?

Compare your label or packaging with the recalled product.

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.
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
71424 bottles.
Illnesses reported
None reported
Manufactured in
3701 Concorde Pkwy, N/A, Chantilly, VA, United States
Classification
Class II
Recall number
D-0305-2026

In the FDA's words

Description
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. Presence of Foreign Tablets/Capsules Batch # 6160008A, Exp Date: 12/31/2026 Distribution: US Nationwide. Affected quantity: 71424 bottles.
Hazard
Presence of Foreign Tablets/Capsules

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