Icosapent Ethyl Capsules Recalled for Failed Tablet Specifications
Zydus Pharmaceuticals is recalling Icosapent Ethyl Capsules due to burnt or melted capsules caused by oxidation from leakage of capsule contents. The recall affects 11,616 bottles distributed in Illinois, Pennsylvania, and Mississippi.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving failed capsule specifications (burnt/melted capsules from oxidation). The source text does not report any hospitalizations, injuries, or illnesses, and the hazard is product defect rather than contamination with a high-risk pathogen. Per the rubric, Class II recalls without reported hospitalization or illness typically score 2 (Moderate).
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Icosapent Ethyl Capsules, 1 gram, 120 capsules per bottle (NDC 70710-1592-7), due to failed tablet/capsule specifications. A product complaint was reported for burnt or melted capsules, determined to result from oxidation caused by leakage of capsule contents.
The affected product includes Lot numbers B237040 and B237041, with an expiration date of 10/31/2025. A total of 11,616 bottles were distributed to patients in Illinois, Pennsylvania, and Mississippi.
Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance. Those who have received affected product should not continue use and should return the product to their pharmacy or contact Zydus Pharmaceuticals for further instructions.
The recalled product
- Product
- ICOSAPENT ETHYL (ICOSAPENT ETHYL)
- Brand
- ICOSAPENT ETHYL
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Prescription Capsule
- Affected units
- 11,616
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
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