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Home » Over 22,000 Bottles of Cholesterol Medication Recalled Across the U.S., FDA Reports
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Over 22,000 Bottles of Cholesterol Medication Recalled Across the U.S., FDA Reports

News RoomBy News RoomFebruary 5, 2026No Comments2 Mins Read
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  • Zydus Pharmaceuticals has recalled 22,896 bottles of Icosapent Ethyl capsules
  • The products were available via prescription and distributed across the U.S.
  • Here’s a list of impacted medication.

Over 22,000 bottles of cholesterol medication have been recalled, according to a U.S. Food & Drug Administration (FDA) report. Certain lots of the medication have been deemed “a subpotent drug.”

Zydus Pharmaceuticals initiated the voluntary recall at the end of December, warning consumers that 22,896 bottles of Icosapent Ethyl capsules may have leaked and caused oxidation, ultimately decreasing the drug’s strength. Additionally, the leakage may cause the capsules to offer “inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.”

Late last month, the FDA classified the recall as a Class II, meaning that it may have temporary or reversible negative health effects. The likelihood of serious health problems caused by the recalled products is “remote.” Still, if you believe you have any of the recalled pills, consult your physician before stopping any medication.

Which products are affected?

The specific Icosapent Ethyl capsules that are a part of the recall were manufactured by Softgel Healthcare, issued via prescription only, and were distributed across the U.S. in 120-count bottles.

You can check to see if you have one of the affected products by matching up the following lot numbers and expiration dates:

Lot number: S2520304

  • Expiration date: 2/28/2027

Lot number: S2520333

  • Expiration date: 2/28/2027

Lot number: S2540186

  • Expiration date: 4/30/2027

This particular recall comes on the heels of another cholesterol medication, atorvastatin calcium, being pulled from shelves. Over 140,000 bottles of the drug were recalled by Ascend Laboratories back in October for concerns over dissolution problems.

What to do with the recalled product

No specific guidelines for discarding the product were provided by the FDA. However, if you have one of the recalled products, you should consult with a medical professional, as continuing to take the drug could result in inefficient treatment.

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