2 More Cholesterol Drugs Have Been Recalled Nationwide

Statins are one of the most-prescribed drugs for the nearly 50 million Americans managing high cholesterol and triglycerides. Last week came a recall affecting more than 57,000 bottles of two-milligram dosage Pitavastatin tablets distributed by New Jersey-based Teva Pharmaceuticals. Now a newer recall announcement from the U.S. Food and Drug Administration (FDA) has named a similar medication, this time for yet a separate concern.

In a report released this weekend amid an FDA investigation, the agency issued an alert regarding a nationwide recall of Pitavastatin. This new recall affects 10,133 total bottles manufactured for Tennessee-based AvKARE. This recall has been called apparently due to “Failed Impurity/Degradation Specifications,” though the report does not further elaborate on the alleged issue.

Pitavastatin, according to the Mayo Clinic, “is used together with a proper diet to lower high cholesterol levels and triglyceride (fat) levels in the blood”—and may help prevent certain serious heart issues, such as stroke or heart attack, linked with “fat clogging the blood vessels.”

Recalled product details include:

Pitavastatin Tablets, 1 milligram (1 mg)

• 90 Tablets per bottle
• Rx Only
• Manufactured for: AvKARE, Pulaski, TN 38478
• NDC (National Drug Code): 42291-905-90
• Lot Codes and Expiry:
  • Lot 46208, exp 10/31/2025
  • Lot 47738, exp 09/30/2026
  • Lot 46943, exp 05/31/2026
• 1,560 total bottles

Pitavastatin Tablets, 2 milligrams (2 mg)

• 90 Tablets per bottle
• Rx Only
• Manufactured for: AvKARE, Pulaski, TN 38478
• NDC: 42291-906-90
• Lot Codes and Expiry:
  • Lot 46211, exp 10/31/2025
  • Lot 47683, exp 05/31/2026
  • Lot 46944 , exp 01/31/2026
• 8,573 total bottles

The recall, which was reportedly first initiated on June 26, was designated on Wednesday, July 16 as a Class III event. Class III recalls, according to the FDA’s guidelines, involve “a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”

The listed recalling firm, AvKARE, was named in a recall earlier this year on more than 1.8 million eye drop products.

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