Icosapent ethyl capsules recalled after active ingredient oxidized inside capsule
Zydus Pharmaceuticals is recalling eight lots of Icosapent Ethyl Capsules 1 gram after red dots and melted capsules were found, caused by oxidation of the active ingredient.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the source attributes the defect to oxidation of the active ingredient itself, not merely to appearance, and no injuries are stated.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling Icosapent Ethyl Capsules, 1 gram, 120 capsules per bottle, prescription only, manufactured by Softgel Healthcare Pvt. Ltd. of India, NDC 70710-1592-7. About 60,541 bottles were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The recall was initiated for failed tablet/capsule specifications: red dots inside the capsule and melted capsules, caused by oxidised icosapent ethyl, the active ingredient.
Affected product covers lots S2520249, S2520250 and S2520267 (expiry January 2027), S2520303, S2520305 and S2520332 (February 2027), and S2540208 and S2540209 (April 2027).
Patients and pharmacies can identify affected product by the NDC and lot numbers above, and may contact Zydus Pharmaceuticals (USA) Inc for further information.
The recalled product
- Product
- ICOSAPENT ETHYL (ICOSAPENT ETHYL)
- Brand
- ICOSAPENT ETHYL
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Prescription capsule
- Affected units
- 60,541
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 (11)
- Lot #: S2520249
- S2520250
- S2520267
- Exp. Date 2027/Jan
- S2520303
- S2520305
- S2520332
- Exp. Date 2027/Feb
- S2540208
- S2540209
- Exp. Date 2027/Apr
UPCs (1)
- 0370710159276
Distribution
Distributed nationwide across the United States.
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