4 Common Types of Cholesterol Medications Have Been Recalled Nationwide

Most of us know someone who’s taking medicine to manage cholesterol levels, if we’re not the ones taking it ourselves. In fact, over 47 million Americans regularly take prescribed cholesterol medications, according to Yale Medicine.

So, it’s important we pay attention to a recent recall of four different types of cholesterol medications from the major pharmaceutical company Glenmark Pharmaceuticals Inc. Each medication has been recalled across the country.

As reported by the U.S. Food and Drug Administration (FDA), the affected products include:

• Fenofibrate capsules (Lipofen generic)
• Pravastatin sodium tablets (Pravachol generic)
• Rosuvastatin tablets (Crestor or Ezallor generic)
• Colesvelam hydrocholoride tablets (WelChol generic)

The reason for the recall is listed as “CGMP Deviations.” The FDA explains that CGMP, which refers to the Current Good Manufacturing Practice regulations, is the “main regulatory standard for ensuring pharmaceutical quality.” The FDA conducts investigations at pharmaceutical manufacturing plants to determine if the medication it produces is effective and safe for the public.

It’s unclear why Glenmark Pharmaceuticals’ products did not meet the CGMP standards. However, CGMP deviations aren’t always tied to the product itself—it could be the result of inappropriately obtained materials, substandard manufacturing operations, or poorly built systems designed to oversee potential product deviations, as examples.

The FDA has labeled the Glenmark Pharmaceuticals event as a Class II recall, meaning ingesting the pills has the potential to cause temporary adverse medical effects. These drugs are part of a large-scale recall of 39 different medications from the pharmaceutical company, with other affected products including heart medication and pain relievers.

The federal agency released the following details about each recalled cholesterol medication:

Fenofibrate, 67 mg—manufactured for Glenmark Pharmaceuticals Inc.

• Amount per bottle: 100 capsules
• National Drug Code (NDC): 68462-580-01
• Lot number: 17230834 or 17230835
• Expiration date: Mar-25

Pravastatin sodium, 20 mg—manufactured for Glenmark Pharmaceuticals Inc.

• Amount per bottle: 90 or 500 tablets
• NDC: 68462-196-90 or 68462-196-05
• Lot number: 17230810, 17230811, 17230810, 17232501, or 17232502
• Expiration date: Mar-26 or Nov-26

Pravastatin sodium, 20 mg—manufactured for Northstar Rx LLC

• Amount per bottle: 90 tablets
• NDC: 16714-559-01
• Lot number: 17230810
• Expiration date: Mar-26

Pravastatin sodium, 80 mg—manufactured for Glenmark Pharmaceuticals Inc.

• Amount per bottle: 90 tablets
• NDC: 68462-198-90
• Lot number: 17221771, 17230930, 17230931, 17231252, 17231274, 17231855, 17231916, 17231917, or 17231945
• Expiration date: Aug-25, Apr-26, May-26, or Aug-26

Pravastatin sodium, 80 mg—manufactured for Northstar Rx LLC

• Amount per bottle: 90 or 500 tablets
• NDA: 16714-570-01 or 16714-570-02
• Lot number: 17221770, 17221774, 17231251, 17231262, 17232112, or 17232133
• Expiration date: Aug-25, May-26, or Sep-26

Rosuvastatin, 40 mg—manufactured for Glenmark Pharmaceuticals Inc.

• Amount per bottle: 30
• NDA: 68462-264-30
• Lot number: 17240389, 17240390, 17240426, 17240427, 17240428, 17240778, 17241055, 17241074, 17241075, 17241091, or 17241100
• Expiration date: Feb-26, Apr-26, May-26, May-26, or Jun-26

Colesvelam hydrocholoride, 625 mg—manufactured for Glenmark Pharmaceuticals Inc.

• Amount per bottle: 180 tablets
• NDC: 68462-433-18
• Lot number: 17240669, 17240876, 17240883, 17240909, 17240914, or 17240927
• Expiration date: Mar-26, Apr-26, or May-26

Though it’s not stated in the FDA recall announcement, if you’re in possession of one of the recalled medications, it’s probably a good idea to contact your pharmacist or doctor to ask about a replacement.

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