Zydus Pharmaceuticals (USA) Inc: Drug Recall

Recall Details

Recall Number

D-0497-2025

Classification

Class II

Product Type

Drug

Recalling Firm

Zydus Pharmaceuticals (USA) Inc

Status

Ongoing

Date Initiated

05/30/2025

Location

Pennington, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

11,616 bottles

Reason for Recall

Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.

Product Description

Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.

Distribution Pattern

IL, PA, & MS

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 →