D-0656-2025Class II

Zydus Pharmaceuticals (USA) Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2025-09-24

Distribution

U.S. Nationwide

Firm state

Product quantity

4344 bottles

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Validation & Qualification

Reason for recall

Failed Impurity/Degradation Specifications

Product description

Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.

Code / lot info

Lot E309376; Exp 11/30/2025

Other recalls SPEQ maps to Validation & Qualification

2026-10-21Class IIZydus Pharmaceuticals (USA) Inc 2026-10-21Class IIIMagellan Diagnostics, Inc.2026-10-21Class IIMicrogenics Corporation 2026-10-14Class IICipla USA, Inc.

See all Validation & Qualification recalls →

Data: U.S. FDA. 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. Open the enforcement explorer →