Quick Facts at a Glance
- Recall Date
- March 9, 2026
- Hazard Level
- HIGH
- Brands
- ICOSAPENT ETHYL, Zydus Pharmaceuticals USA
- 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
- ICOSAPENT ETHYL, Zydus Pharmaceuticals USA
- Product type
- Icosapent Ethyl Capsules
- Model numbers
- Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan, S2520303, S2520305, S2520332, Exp. Date 2027/Feb +3 more
- UPC codes
- 70710-1592, 70710-1738, 70710-1738-4, 70710-1592-7
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 9, 2026
Reported by FDA DRUG
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
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 is a prescription omega-3 fatty acid therapy used to treat high triglyceride levels. The 1 g capsule comes in a 120-count bottle and is distributed nationwide in the United States.
Why This Is Dangerous
Oxidation of the active ingredient can produce physical changes in the capsule, including red dots and melting, which may affect safety and efficacy.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Patients using this prescription therapy may need to discontinue use and seek clinician guidance. The recall could disrupt ongoing treatment for high triglycerides.
Practical Guidance
How to identify if yours is affected
- Verify the product is Icosapent Ethyl Capsules, 1 g, 120-count, Rx only.
- Check NDC 70710-1592-7 on the bottle.
Where to find product info
FDA recall page for D-0400-2026 and the recall notice from Zydus Pharmaceuticals USA Inc.
What timeline to expect
Refund or replacement timelines are not specified. Follow recall instructions in the notification letter.
If the manufacturer is unresponsive
- Document all communications with Zydus Pharmaceuticals USA Inc.
- If the company is slow, contact your healthcare provider for guidance and consider filing a complaint with the FDA.
- Keep copies of all notices and correspondence.
How to prevent similar issues
- Verify NDC and lot numbers when receiving prescriptions.
- Report any adverse events to your clinician and the FDA if observed.
- Keep recall notifications for future reference.
Documentation advice
Retain recall letters, bottle labels, NDC, lot numbers, Expiration dates, and any correspondence with the company or clinician.
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Product Details
Product: Icosapent Ethyl Capsules, 1 g, 120 capsules per bottle, Rx only Manufacturer: Softgel Healthcare Pvt. Ltd., India Distributor: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534 NDC: 70710-1592-7 Recall date: 2026-03-09 Quantity: 60,541 bottles Distribution: Nationwide in the United States Lot numbers/exp dates: Lot #: S2520249; S2520250; S2520267; Exp. Date 2027/Jan; S2520303; S2520305; S2520332; Exp. Date 2027/Feb; S2540208; S2540209; Exp. Date 2027/Apr
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Exp. Dates 2027/Jan, 2027/Feb, 2027/Apr
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Safety Guide
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