Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Dist
Summary
The FDA issued a Class II for Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: S by Zydus Pharmaceuticals (USA) Inc. Reason: Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules.
Details
Source
Drug Recall
External ID
D-0295-2026
Action Date
2026-01-28
Status
Ongoing
Category
drug
Product Description
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
Lot/Code Info: Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
Quantity Affected: 22,896 bottles
Reason for Recall
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-30
Company
Pennington, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 67 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Zydus Pharmaceuticals (USA) Inc has 47 FDA actions in our database, including 47 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zydus Pharmaceuticals (USA) Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zydus Pharmaceuticals (USA) Inc have FDA actions?
Zydus Pharmaceuticals (USA) Inc has 47 FDA actions in our database, including 47 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0295-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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