Class II U.S. Food and Drug Administration

Zydus Pharmaceuticals Inc Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle recall: Failed Tablet/Capsule specifications: Red dots inside capsule and melted

Recall published 7 months ago

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

The hazard: Fire or burn hazard

This product can overheat or catch fire, which is why the instruction is to unplug and stop using it rather than to keep an eye on it.

What the notice says: Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

Why it matters: The product can overheat, ignite or cause a burn. Where lithium batteries are involved the failure is fast and very hot, and water does not put it out quickly.

Symptoms and when to call a doctor

Treat a burn by cooling it under running water for about 20 minutes — not with ice, butter or ointment — and cover it loosely with a clean non-fluffy cloth. Get medical help for burns that are larger than the person’s palm, that are deep or white or charred, that involve the face, hands, feet or genitals, or any burn to a baby or young child. If someone has inhaled smoke and is coughing, hoarse or short of breath, call 911.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0400-2026
Published
March 18, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Zydus Pharmaceuticals Inc
Product type
Prescription & OTC drugs
Units affected
60,541 bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr

Products covered by this recall

Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • S2520249
  • S2520250
  • S2520267

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2027
  • Apr — 60
  • 541 bottles

NDC number

On the carton and again on the bottle or blister label.

  • 70710-1592-7

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 gram

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fire

Zydus Pharmaceuticals Inc — This product can overheat or catch fire, which is why the instruction is to unplug and stop using it rather than to keep an eye on it.

  1. Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.
  2. Do not leave it charging overnight or while the house is empty while you wait for the remedy.
  3. If it has already overheated, scorched or swelled, do not keep using it and do not try to repair it.
  4. Check that your smoke alarms work while you are thinking about it, and follow the remedy on this page.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • Have the model number, the date code and your photos ready. Many companies issue store credit by default — ask for cash or a card reversal if you would rather have it.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.
  • If you bought it from a retailer rather than the brand, try both. Target, Walmart and Amazon often refund recalled goods from the order history.

Company contact: Zydus Pharmaceuticals (USA) Inc — 73 Route 31 N, Pennington, NJ, 08534-3601

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Zydus Pharmaceuticals Inc prescription & otc drugs recalled?

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code S2520249, S2520250, S2520267; best-by date 2027 or Apr — 60. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.

Can I get my money back?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

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