Recall
FDAHealthJanuary 26, 2026

Granules Pharmaceuticals Inc. — Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceu

⚠️ Presence of Foreign Tablets/Capsules

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
January 26, 2026

US Nationwide.

What's affected?

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

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 71424 bottles..

View original FDA notice →

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