FDA recall D-0305-2026

Granules Pharmaceuticals Inc. · Class II · drug

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.

Reason for recall

Presence of Foreign Tablets/Capsules

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2026-01-26
Report date
2026-02-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chantilly, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0305-2026