Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Trazodone Hydrochloride Recalled by Granules Pharmaceuticals Inc. Due to Presence of Foreign Tablets/Capsules

Date: January 26, 2026
Company: Granules Pharmaceuticals Inc.
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Granules Pharmaceuticals Inc. directly.

Affected Products

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.

Quantity: 71424 bottles.

Why Was This Recalled?

Presence of Foreign Tablets/Capsules

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Granules Pharmaceuticals Inc.

Granules Pharmaceuticals Inc. has 10 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report