Zydus Pharmaceuticals (USA) Inc: Drug Recall

Recall #D-0657-2025 · 09/04/2025

Class II: Risk

Recall Details

Recall Number: D-0657-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Status: Ongoing
Date Initiated: 09/04/2025
Location: Pennington, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4440 bottles

Reason for Recall

Failed Impurity/Degradation Specifications

Product Description

Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

Distribution Pattern

U.S. Nationwide

Other Recalls by Zydus Pharmaceuticals (USA) Inc

Class II: Risk 12/30/2025

Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.
Class III: Low Risk 12/19/2025

Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Class II: Risk 10/23/2025

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Class II: Risk 10/22/2025

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II: Risk 10/22/2025

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

View all recalls by Zydus Pharmaceuticals (USA) Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.