American Health Packaging has issued a voluntary recall for 14,360 bottles of Lovastatin Tablets USP (40 mg), a prescription medication used to lower cholesterol. The recall includes both 100-count and 1,000-count bottles. This action was taken because the drug substance used to manufacture the tablets was found to have impurity results that were out of specification, which means the product did not meet the required quality standards. These products were distributed nationwide across the United States and Puerto Rico.
The product was manufactured using a drug substance that failed to meet established purity standards, potentially exposing consumers to unintended impurities. While this specific recall is classified as a low-level risk, medication that does not meet quality specifications may not perform as intended or could contain substances not verified for safety.
Drug recall guidance for consumers
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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