FDA Recall D-0295-2026

Zydus Pharmaceuticals (USA) Inc · Pennington, NJ

Class II Ongoing 135 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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: Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027

Quantity: 22,896 bottles

Reason for recall

Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules

Recall record

Recall number: D-0295-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide.
Recall initiated: 2025-12-30
Classified by FDA Center: 2026-01-22
FDA published: 2026-01-28
Recalling firm: Zydus Pharmaceuticals (USA) Inc
Firm location: Pennington, NJ

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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