Icosapent Ethyl Capsules Recalled for Subpotency Due to Capsule Leakage
Zydus Pharmaceuticals is recalling Icosapent Ethyl capsules nationwide due to oxidation caused by capsule leakage, which reduces drug potency. Approximately 22,896 bottles are affected.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is subpotency resulting from oxidation and capsule leakage, representing a loss of therapeutic efficacy rather than an acute safety threat.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling Icosapent Ethyl capsules (1 gram, 120-count bottles, prescription only) distributed nationwide. The recall affects approximately 22,896 bottles with the following lot numbers: S2520304, S2520333 (expiration 2/28/2027), and S2540186 (expiration 4/30/2027).
The recalled product is subpotent due to oxidation caused by leakage from the capsules. This reduces the medication's potency and effectiveness below intended levels.
Patients currently using this medication should contact their pharmacy or healthcare provider to determine if they have an affected lot and to discuss next steps. Do not stop taking your medication without first consulting your doctor. For more information, contact Zydus Pharmaceuticals or your pharmacy.
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
- Hazard
- subpotency
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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