Drug Enforcement 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.

Status

Ongoing

Classification

Class II

Report Date

June 18, 2025

Termination Date

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Product Information

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.
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
IL, PA, & MS

Location & Firm

Recalling firm
Zydus Pharmaceuticals (USA) Inc
Address
73 Route 31 N

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0497-2025
Event ID
96964
Recall initiation date
May 30, 2025
Center classification date
June 30, 2025
Code info
Lot #s: B237040, B237041, Exp 10/31/2025
More code info
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