← FDA ENFORCEMENT
D-0305-2026Class II

Granules Pharmaceuticals Inc.

Recalling firm
Granules Pharmaceuticals Inc.
Product type
Drug
Status
Ongoing
Report date
2026-02-11
Distribution
US Nationwide.
Firm state
VA
Product quantity
71424 bottles.
Initiated by
Voluntary: Firm initiated
Reason for recall

Presence of Foreign Tablets/Capsules

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.

Code / lot info

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

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.