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Class II · ModerateActive recall

Icosapent Ethyl

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #s: B237040, B237041, Exp 10/31/2025
Where it was soldIL, PA, & MS
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

Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byDoppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 foreign manufacturer
Brand nameICOSAPENT ETHYL
Generic nameICOSAPENT ETHYL
Active ingredient(s)ICOSAPENT ETHYL
Distributed by / forZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
NDC70710-1592-7
Show the full FDA record
Full product labelIcosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.
Recalling firmZydus Pharmaceuticals (USA) Inc
DistributionIL, PA, & MS
Quantity11,616 bottles
Recall initiated2025-05-30
Report date2025-06-18
Recall completed—
Recall numberD-0497-2025
ClassificationClass II
FDA statusOngoing
Origin on filePennington NJ United States

Related

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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.