[pending] Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pv
Pending LLM rewrite. Source: FDA_DRUG D-0295-2026.
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
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
The recalled product
- Product
- Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
- 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 (5)
- Lot # S2520304
- S2520333
- Exp 2/28/2027
- S2540186
- Exp 4/30/2027
Distribution
Distributed nationwide across the United States.
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