Class IIOngoing

Trazodone Hydrochloride recall

FDA recall D-0305-2026 · initiated Jan 26, 2026

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Presence of Foreign Tablets/Capsules

Details

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.
Recalling company: Granules Pharmaceuticals Inc
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: US Nationwide.
Initiated: Jan 26, 2026
FDA report date: Feb 11, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0305-2026 ↗

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