Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only
Recalled by Granules Pharmaceuticals Inc.
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Granules Pharmaceuticals Inc. has recalled Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on February 11, 2026 and was initiated on January 26, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, with approximately 71424 bottles. affected. The company behind the recall is Granules Pharmaceuticals Inc., based in Chantilly, VA. The FDA describes the product as: “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.”
Why was Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only recalled?
According to the FDA, the stated reason for the recall is: “Presence of Foreign Tablets/Capsules.”
What should you do?
If you think you may have bought Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, compare it against the product description and identifying codes (Batch # 6160008A, Exp Date: 12/31/2026) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Granules Pharmaceuticals Inc. or your local health authority.
About this recall
This recall was distributed in VA. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- February 11, 2026
- Recall started
- January 26, 2026
- Distributed in
- VA
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only recalled?+
According to the FDA: Presence of Foreign Tablets/Capsules
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0305-2026. Information last synced from the FDA on July 5, 2026.