Granules Pharmaceuticals Inc. Recalls Trazodone Hydrochloride Due to Foreign Tablets

What Happened

Granules Pharmaceuticals Inc. has initiated a voluntary Class II recall of Trazodone Hydrochloride tablets. The recall was issued following reports of the presence of foreign tablets or capsules within the medication bottles, which were manufactured by Granules India Limited.

Which Products Are Affected

The recall involves Trazodone Hydrochloride, USP, 50 mg, distributed in 100-count bottles. The following specific details identify the affected products:

• Product Name: Trazodone Hydrochloride, USP, 50 mg
• Manufacturer: Granules Pharmaceuticals Inc.
• NDC Number: 70010-231-01
• Batch Number: 6160008A
• Expiration Date: 12/31/2026
• UPCs: 0370010231030, 0370010232037, 0370010234031, 0370010233034
• Quantity: 71,424 bottles
• Distribution: Nationwide across the United States

What You Should Do

Consumers who have the affected batch of Trazodone Hydrochloride should immediately stop using the medication. You should contact your healthcare provider to discuss alternative treatments and reach out to Granules Pharmaceuticals Inc. in Chantilly, VA, for further instructions regarding the return or disposal of the product.

Why This Matters

The presence of foreign tablets or capsules in a prescription medication bottle poses a significant health risk, as patients may accidentally ingest the wrong drug, leading to potentially serious adverse reactions or medical complications.

Source

Attribution: FDA (Recall Number: D-0305-2026)