FDAClass IIFebruary 11, 2026

Trazodone Hydrochloride recall

Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for…

Why was Trazodone Hydrochloride recalled?

Presence of Foreign Tablets/Capsules

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch # 6160008A, Exp Date: 12/31/2026

Product
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for…
Recalling firm
Granules Pharmaceuticals Inc.
Quantity
71424 bottles.
Distribution
US Nationwide.
Recall date
February 11, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls