FDA Drugs recall ·
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only… recall
- Recall number
- D-0497-2025
- Date
- (initiated May 30, 2025)
- Company / brand
- Zydus Pharmaceuticals (USA) Inc
73 Route 31 N, Pennington, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 11,616 bottles
- Hazard tags
- Burn
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #s: B237040, B237041, Exp 10/31/2025
Distribution
IL, PA, & MS
States: Illinois Mississippi Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0497-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.