[pending] ICOSAPENT ETHYL (ICOSAPENT ETHYL)
Pending LLM rewrite. Source: FDA_DRUG D-0497-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- ICOSAPENT ETHYL (ICOSAPENT ETHYL)
- Brand
- ICOSAPENT ETHYL
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Drugs
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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