Prescription Naproxen Oral Solution Recalled Nationwide Over Chemical Contamination Concerns

By Ginika Igboke

Thousands of bottles of a prescription-only pain reliever and fever medication have been recalled across the United States because of chemical contamination, according to a recall notice released last week by the Food and Drug Administration (FDA).

The recall affects 6,336 bottles of prescription naproxen oral solution, sold in 125 milligram per 5 milliliters strength in 16-ounce bottles. The affected products include one lot numbered 23F02 with an expiration date of May 2026, and another lot numbered 25A37 with an expiration date of January 2028.

The FDA said the recall was initiated because of the “presence of lead and lithium above specification.”

The medication was distributed by Georgia-based Acella Pharmaceuticals and manufactured in Canada, according to the FDA notice. No additional information was provided regarding how the contamination occurred, and the company did not release a public statement about the recall.

Although the recall began in April, the FDA officially classified it on May 6 as a Class II recall. The agency defines a Class II recall as a situation in which use of or exposure to a product “may cause temporary or medically reversible adverse health consequences” and where the likelihood of serious health effects is considered remote.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to relieve pain, inflammation, swelling, and stiffness associated with conditions such as arthritis, bursitis, gout, and menstrual cramps. It is also the active ingredient in over-the-counter medications such as Aleve.

The medication remains one of the most widely used pain relievers in the United States. According to drug database ClinCalc, more than 6 million prescriptions for naproxen were filled in 2023.

The FDA notice did not explain how lithium or lead may have entered the recalled medication.

Lithium is commonly prescribed to treat bipolar disorder and mania. Health officials have long warned that the metal has a narrow therapeutic index, meaning there is only a small margin between a safe dose and a potentially dangerous overdose.

Lead exposure also poses health risks. The U.S. Centers for Disease Control and Prevention says lead can sometimes be found in imported foods, cosmetics, and traditional medicines, and that laboratory testing is usually required to detect contamination.

In recent years, several consumer products—including cinnamon-containing foods and children’s fruit snacks sold nationwide—have also been recalled after testing revealed elevated levels of lead.