Warning
Granules Pharmaceuticals Inc. Recalls Trazodone Hydrochloride
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0305-2026Drug / Pharmaceutical
Granules Pharmaceuticals Inc. Recalls Trazodone Hydrochloride
Granules Pharmaceuticals Inc. · Class II — Moderate Risk
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.
Reason for Recall
Presence of Foreign Tablets/Capsules
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a pharmaceutical product from Granules Pharmaceuticals Inc., initiated on January 26, 2026. Presence of Foreign Tablets/Capsules. This recall covers 71424 bottles., distributed in US Nationwide. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.