May 2025 FDA Recall Icosapent Ethyl by Zydus Pharmaceuticals (usa) Inc (D-0497-2025 - 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.)

This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on May 30, 2025 for the product Icosapent Ethyl. The FDA reported the reason for recall as 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.. The product was distributed in IL, PA, & MS and the recall is currently ongoing.

Recall Number: D-0497-2025

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.
Initiated
05-30-2025
Reported
06-18-2025
Quantity
11,616 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96964
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
IL, PA, & MS
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# s: B237040, B237041, Exp 10/31/2025

Affected Packages Involved in this Recall

70710-1738-4 Icosapent Ethyl
70710-1592-7 Icosapent Ethyl