Thousands of bottles of a prescription-only pain reliever and fever medication were recalled nationwide due to chemical contamination, according to a Food and Drug Administration (FDA) recall notice released last week.
According to the notice, 6,336 bottles of prescription naproxen oral solution in 125 milligram per 5 milliliters in 16-ounce bottles are under recall. The medication under recall has a lot number of 23F02 and an expiration date of May 2026, and another has a lot number of 25A37 and an expiration date of January 2028.
The reason for the recall was due to what it said was the “presence of lead and lithium above specification.”
It was distributed by Georgia-based Acella Pharmaceuticals LLC and made in Canada, according to the FDA notice. No other details were released about the action, and Acella did not issue a press release about the recall.
The recall was initiated last month, but the FDA on May 6 labeled it as a Class II recall, or what the agency says is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Naproxen is the active ingredient in a number of commonly used over-the-counter medications, namely Aleve. It’s classified as a nonsteroidal anti-inflammatory drug (NSAID) that is used to relieve moderate pain, inflammation, swelling, and stiffness caused by a number of conditions including menstrual cramps, gout, arthritis, bursitis, and others.
The drug is one of the most widely used over-the-counter medications in the United States, with Aleve and similar products being sold in numerous stores. It’s also commonly prescribed, according to drug database ClinCalc, with more than 6 million prescriptions filled in 2023.
The recall notice did not say why the product came to potentially contain lithium or lead.
Lithium is often used as a treatment for bipolar disorder and mania, according to the Mayo Clinic. The metal also has a narrow therapeutic index, meaning that there is a small difference between a safe dose and an overdose, U.S. health officials say.
Regarding lead, the U.S. Centers for Disease Control and Prevention says on its website that lead is sometimes “found in certain foods, cosmetics, and traditional medicines imported from other countries.” It’s difficult to detect lead in products, and its presence can only be detected in a laboratory, the agency says.