Recalls / Class II
Class IID-0497-2025
Product
Icosapent 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.
- Brand name
- Icosapent Ethyl
- Generic name
- Icosapent Ethyl
- Active ingredient
- Icosapent Ethyl
- Route
- Oral
- NDCs
- 70710-1592, 70710-1738
- FDA application
- ANDA217656
- Affected lot / code info
- Lot #s: B237040, B237041, Exp 10/31/2025
Why it was recalled
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.
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 11,616 bottles
- Distribution pattern
- IL, PA, & MS
Timeline
- Recall initiated
- 2025-05-30
- FDA classified
- 2025-06-30
- Posted by FDA
- 2025-06-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0497-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.