More than 57,000 Bottles of a Cholesterol Medication Have Been Recalled in One State

Heart disease is the number one cause of death in the U.S., so following doctor-approved recommendations—such as taking medication for high cholesterol—could make a massive difference in your overall wellness. Yet health experts estimate that just over half of American adults who should be taking this type of medication actually do.

But if you’re one of the approximately 47 million Americans who are currently taking a prescription drug to help lower cholesterol, you’ll want to check the label on your medication bottle in light of a new notice.

On Thursday, the U.S. Food and Drug Administration (FDA) announced a recall of 57,504 bottles of 2-milligram (mg) pitavastatin tablets. Each bottle contains 90 tablets.

Pitavastatin, a cholesterol-lowering drug in the statin family, is a prescription medication that can be associated with brand names such as Livalo and Zypitamag, says the Cleveland Clinic.

According to the FDA’s report, the drug was recalled due to “Failed Impurities/Degradation Specifications.” Further details about the apparent issue were not provided.

It appears that the affected medication was distributed to only one state: New Jersey.

The FDA shared the following details:

• Pitavastatin Tablets, 2 mg
• Rx Only
• 90 Tablets
• National Drug Code (NDC): 0480-3632-98
• Code Information:
  • P061001, P061002, P061003, P061004, P061006, & P061007, Exp Date 07/2025
  • P061008, Exp Date 08/2025
  • P061009 & P061010, Exp Date 10/2025
  • P061011, P061012, & P061013, Exp Date 01/2026
  • P061016, P061017, & P061018, Exp Date 04/2026
  • P061019, Exp Date 05/2026
  • P061023, Exp Date 01/2027
• Manufactured by: Orient Pharma Co., Ltd. in Taiwan
• Manufactured for: Teva Pharmaceuticals in Parsippany, New Jersey
• Product of Taiwan

Orient Pharma Co., Ltd. Yunlin Plant in Taiwan is listed as the recalling firm. Evidently, the company voluntarily initiated the recall on June 11. However, the FDA didn’t assign the recall a Class III label until Wednesday, July 16.

Class III recalls involve situations in which “use of or exposure to a violative product is not likely to cause adverse health consequences,” per the FDA website.

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