Class II · ModerateActive recall
Icosapent Ethyl capsules
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made bySoftgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 foreign manufacturer
| Distributed by / for | Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 |
| NDC | 70710-1592-07 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
| Distribution | US Nationwide. |
| Quantity | 22,896 bottles |
| Recall initiated | 2025-12-30 |
| Report date | 2026-01-28 |
| Recall completed | — |
| Recall number | D-0295-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Pennington NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.