More Than 29,000 Prescription Drugs for Metabolic Health Recalled ‘Within U.S.’

Drugs to address metabolic health issues have gained mainstream awareness, but for individuals with underactive thyroid, one class of drug has been trusted for some time. This week one of those has garnered a warning from the U.S. Food and Drug Administration (FDA).

In an August 9 enforcement report, the FDA announced the recall of 29,004 bottles of Levoxyl (levothyroxine sodium tablets). Major pharmaceutical drug company Pfizer is listed as both the recalling firm and distributor. The FDA lists the affected drug’s distribution pattern as being “within U.S.,” possibly making this recall nationwide.

“Subpotent drug” is denoted as the recall reason, suggesting the tablets may contain a reduced strength or potency in comparison to the indicated dosage.

Levoxyl, a brand name for the generic Levothyroxine, is prescribed when the thyroid gland doesn’t produce enough thyroid hormone on its own—a condition which may be diagnosed as hypothyroidism, according to the Mayo Clinic. Mayo adds that the medication may also be prescribed “to help decrease the size of enlarged thyroid glands (also called a goiter),” as well as some types of thyroid cancer.

Hypothyroidism is a fairly common medical condition, as the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) says nearly five out of every 100 Americans ages 12 and older have hypothyroidism. Additionally, the American Association of Clinical Endocrinology states that “most” of the estimated 30 million Americans with thyroid dysfunction have hypothyroidism. Possible hypothyroidism symptoms include fatigue, weight gain, muscle and joint pain, dry skin, thinning hair, or depression. Hypothyroidism is more common among women, and risk may increase with age or hormonally related medical events, such as following pregnancy.

Recalled product details, according to the FDA report:

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

Though first executed on July 29, the FDA has now declared the recall, as of August 8, to be a Class II event, meaning FDA scientists determine the medication “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

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