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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98227

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 30, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Zydus Pharmaceuticals (USA) Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0295-2026
Recall number
D-0295-2026
Initiated
December 30, 2025
Classification
Class II
Status
Ongoing
Quantity
22,896 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

US Nationwide.