Prescription Icosapent Ethyl capsules recalled for capsule integrity failure
Zydus Pharmaceuticals is recalling 11,616 bottles of Icosapent Ethyl capsules due to burnt or melted capsules caused by oxidation from internal leakage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification and capsule integrity failure represent a risk-of-harm product. No illnesses or injuries have been reported in the available source material. The hazard—capsule defects and oxidation—could compromise medication stability and efficacy.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling 11,616 bottles of Icosapent Ethyl 1-gram capsules (120 per bottle) distributed in Illinois, Pennsylvania, and Mississippi. Affected lot numbers are B237040 and B237041 with expiration date 10/31/2025.
The FDA classified this as a Class II recall due to failed capsule specifications. A product complaint reported burnt or melted capsules caused by oxidation from internal leakage of capsule contents.
Consumers with affected bottles should contact their pharmacy or healthcare provider for guidance on next steps.
The recalled product
- Product
- ICOSAPENT ETHYL (ICOSAPENT ETHYL)
- Brand
- ICOSAPENT ETHYL
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug
- Hazard
- defective-capsule
- oxidation
- leakage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #s: B237040
- B237041
- Exp 10/31/2025
UPCs (1)
- 0370710159276
Distribution
Distributed in 3 states:
- IL
- MS
- PA
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