Zydus Pharmaceuticals (USA) Inc: Drug Recall

Recall Details

Recall Number

D-0247-2026

Classification

Class III

Product Type

Drug

Recalling Firm

Zydus Pharmaceuticals (USA) Inc

Status

Ongoing

Date Initiated

12/19/2025

Location

Pennington, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

2,136 1000-count bottles

Reason for Recall

Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.

Product Description

traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10

Distribution Pattern

Nationwide in the USA

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 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.
• 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 →