Drug recall
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt…
FDA recall event 98560 · Class II · Zydus Pharmaceuticals (USA) Inc
Key facts
| Event ID | 98560 |
|---|---|
| Recall numbers | D-0400-2026 |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
| Product type | Drugs |
| Products | Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. |
| Initiation date | Mar 9, 2026 |
| Report date | Mar 18, 2026 |
| City | Pennington |
| State | NJ |
| Country | United States |
| FEI number | 3008444937 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: