Quick Facts at a Glance
- Recall Date
- December 30, 2025
- Hazard Level
- HIGH
- Brand
- Zydus Pharmaceuticals
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Zydus Pharmaceuticals
- Product type
- Icosapent Ethyl Capsules
- Model numbers
- Lot # S2520304, S2520333, Exp 2/28/2027, S2540186, Exp 4/30/2027
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 30, 2025
Reported by FDA DRUG
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: Letter
About This Product
Icosapent Ethyl capsules are a prescription medication used to lower triglyceride levels in patients at risk for cardiovascular disease. These capsules are typically prescribed to improve overall heart health and are taken as directed by healthcare providers.
Why This Is Dangerous
The capsules may lose potency due to leakage, leading to inconsistent therapeutic effects. Patients may not receive the intended benefits, and some may experience increased gastrointestinal side effects due to the degradation of the drug.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face health risks due to the potential ineffectiveness of the medication. This could lead to increased triglyceride levels and related health issues, making prompt action necessary.
Practical Guidance
How to identify if yours is affected
- Check the lot number on your bottle against the recalled lot numbers: S2520304, S2520333, S2540186.
- Verify the expiration dates: February 28, 2027, and April 30, 2027.
- Contact your pharmacy or Zydus Pharmaceuticals if you are unsure about your product.
Where to find product info
The lot number and expiration date can typically be found on the label of the bottle or packaging.
What timeline to expect
Expect a refund or resolution within 4-6 weeks after contacting Zydus Pharmaceuticals.
If the manufacturer is unresponsive
- Follow up with Zydus Pharmaceuticals if you do not receive a response within a week.
- Consider filing a complaint with the FDA if the company remains unresponsive.
How to prevent similar issues
- Always check for recalls before using prescription medications.
- Consult with your healthcare provider about alternative medications if you are affected by this recall.
- Be aware of signs of degradation in medication packaging, such as unusual leaks or discoloration.
Documentation advice
Keep a record of any communications you have regarding the recall, including emails, letters, and phone call notes.
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Product Details
The recall involves Icosapent Ethyl capsules, 1 gram, in 120-count bottles. The affected lot numbers include S2520304, S2520333, and S2540186, with expiration dates of February 28, 2027, and April 30, 2027. These products were manufactured by Softgel Healthcare Pvt. Ltd. in India.
Key Facts
- Recall date: December 30, 2025
- Distributed by: Zydus Pharmaceuticals (USA) Inc.
- Quantity recalled: 22,896 bottles
- Manufactured in India
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Safety Guide
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