Icosapent ethyl capsules recalled as subpotent after capsule contents leaked
Zydus Pharmaceuticals is recalling 22,896 bottles of Icosapent Ethyl capsules, 1 gram, because oxidation caused by leakage of the capsule contents has left them subpotent.
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: Scored 3 under the risk-of-harm criterion: a subpotent capsule delivers less active substance than labelled, and no injuries are reported.
Plain-English summary
Icosapent Ethyl capsules, 1 gram, in 120-count bottles, Rx only, manufactured by Softgel Healthcare Pvt. Ltd. of India and distributed by Zydus Pharmaceuticals (USA) Inc. of Pennington, New Jersey, under NDC 70710-1592-07, are being recalled.
The reason given in the enforcement record is a subpotent drug, due to oxidation caused by leakage of the contents of the capsules.
The record lists 22,896 bottles from lots S2520304 and S2520333, expiry 2/28/2027, and lot S2540186, expiry 4/30/2027. Distribution was nationwide in the US. The FDA has classified the action as Class II.
A subpotent capsule delivers less active substance than labelled. Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
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 — Lipid-lowering agent
- Affected units
- 22,896
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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