PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: February 11, 2026 Initiated: January 26, 2026 #D-0305-2026

Product 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.

Reason for Recall

Presence of Foreign Tablets/Capsules

Details

Units Affected
71424 bottles.
Distribution
US Nationwide.
Location
Chantilly, VA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Granules Pharmaceuticals Inc.. Units affected: 71424 bottles..
Why was this product recalled?
Presence of Foreign Tablets/Capsules
Which agency issued this recall?
This recall was issued by the FDA Drug on February 11, 2026. Severity: Moderate. Recall number: D-0305-2026.