"FDA Warning: 29,000 Levoxyl Pills Recalled for Subpotency Within U.S."

Concerns Over Recall of Prescription Drugs for Metabolic Health in the U.S.

Prescription drugs used to address metabolic health issues have become increasingly popular in recent years. However, a recent warning from the U.S. Food and Drug Administration (FDA) has raised concerns about the safety of one particular class of drugs, especially for individuals with underactive thyroid.

In an enforcement report dated August 9, the FDA announced the recall of 29,004 bottles of Levoxyl (levothyroxine sodium tablets), a medication commonly used to treat hypothyroidism. The recall was initiated by major pharmaceutical company Pfizer, who also distributed the product. The recall affects drugs distributed within the U.S., indicating that it may have a nationwide impact.

The reason cited for the recall is the presence of subpotent drug, which indicates that the tablets may not contain the intended strength or potency as indicated on the label.

Understanding the Importance of Levoxyl Medication

Levoxyl, a brand name for the generic Levothyroxine, is prescribed to individuals whose thyroid gland does not produce enough thyroid hormone on its own, a condition known as hypothyroidism. According to the Mayo Clinic, Levoxyl may also be used to reduce the size of enlarged thyroid glands and in the treatment of certain types of thyroid cancer.

Hypothyroidism is a common medical condition, affecting nearly five out of every 100 Americans aged 12 and older, as reported by the National Institute of Diabetes and Digestive and Kidney Disease. The American Association of Clinical Endocrinology estimates that the majority of the 30 million Americans with thyroid dysfunction have hypothyroidism. Symptoms of hypothyroidism may include fatigue, weight gain, muscle and joint pain, dry skin, thinning hair, and depression. The condition is more prevalent among women and may be associated with age or hormonal changes, such as post-pregnancy.

Details of the Recalled Product

According to the FDA report, the recalled Levoxyl product details are as follows:

• Levoxyl (levothyroxine sodium tablets, USP) 50 micrograms (mcg)
• 100-count bottle
• Prescription only
• Lot #: 24C11
• Expiration Date: 2/28/2026
• Distributed by: Pfizer Inc., New York, NY 10017
• Manufactured in Austria
• National Drug Code (NDC): 60793-851-01

While the recall was initially implemented on July 29, the FDA officially classified it as a Class II recall on August 8. This designation indicates that while the medication may cause temporary or reversible adverse health effects, the probability of serious consequences is low.

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The recall of over 29,000 bottles of Levoxyl highlights the importance of ensuring the safety and efficacy of prescription drugs for metabolic health, particularly for individuals with thyroid conditions.