Recall Alert: Orient Pharma and AvKARE Pull Nearly 80,000 Bottles of Cholesterol Drug

In a significant move affecting the pharmaceutical industry, two companies have initiated recalls of the cholesterol-lowering medication pitavastatin due to quality concerns. Taiwanese manufacturer Orient Pharma and Tennessee-based AvKARE have collectively pulled almost 80,000 bottles from the market, citing failed impurity and degradation specifications.

Recall Details and Scope

Orient Pharma, producing the drug for Teva Pharmaceuticals, launched a recall of 57,504 bottles on June 11. The affected products were primarily distributed in New Jersey. Separately, AvKARE issued a recall on June 26, covering 10,133 bottles of pitavastatin that were distributed nationwide. The AvKARE recall encompasses multiple lots with expiration dates ranging from October 31, 2025, to September 30, 2026.

Both recalls have been classified as Class III by the FDA, indicating that while regulations have been violated, the use of these products is unlikely to cause adverse health consequences.

Impact on Statin Market

This recall is particularly noteworthy given the widespread use of statins in the United States. According to CDC estimates from 2018, approximately 92 million adults in the country were taking statins, representing about 35% of adults aged 40 or older.

The pitavastatin recall is not an isolated incident in the statin market. In 2021, Dr. Reddy's faced a similar situation, recalling hundreds of thousands of bottles of atorvastatin, a generic version of Lipitor, due to impurity concerns. That recall, also classified as Class III, affected 10,440 90-count bottles and 224,710 500-count bottles.

Industry Implications

These recalls underscore the ongoing challenges in maintaining stringent quality control in pharmaceutical manufacturing. As one of the most prescribed drug classes in the U.S., statins are subject to intense scrutiny, and any quality issues can have far-reaching effects on patient care and industry reputation.

While the current recalls are not expected to cause immediate health risks, they highlight the importance of rigorous testing and the potential for supply chain disruptions in the pharmaceutical industry. As companies work to address these quality control issues, the incident serves as a reminder of the complex balance between mass production of essential medications and maintaining the highest standards of drug purity and stability.