When you need relief from fever or common aches and pains, choices tend to be aspirin, acetaminophen (best known by the name Tylenol), ibuprofen (often, Advil), or naproxen, which is an active ingredient in the brand name Aleve.
A generic version of naproxen has been recalled by a major pharmaceutical manufacturer, as the U.S. Food and Drug Administration (FDA) reports this week that “Chemical contamination; presence of lead and lithium above specification” were observed as a concern in Naproxen Oral Solution, a liquid version of the drug. The report indicates that the recall affects prescription-strength naproxen made by Acella Pharmaceuticals, LLC, in 125 milligrams per five milliliter (125 mg/5 mL) bottles. The company has offices in Georgia, though the product is reportedly made in Canada.
The report states 6,336 bottles of prescription liquid naproxen—with a National Drug Code (NDC) of 42192-619-16—have been recalled. Identifying details are:
- Lot number 23F02 with expiration 05/2026
- Lot number 25A37 with expiration 01/2028
How the drug came to possibly contain lead or lithium is not stated in the report. The Cleveland Clinic explains lithium “is a natural salt that reduces the symptoms of mania. Healthcare providers mainly prescribe it for bipolar disorder. The medication has a narrow range of safety, so it doesn’t take much to have too much lithium in your body.” Their experts add that lithium toxicity can be fatal.
As for possible presence of lead, the Centers for Disease Control and Prevention (CDC) states: “Lead can be found in some products from other countries.” A recent recall on herbal supplements helped illuminate how raw material such as lead can enter the product via soil, water, or air.
The recall is said to have been initiated on April 20, and on May 6 classified as a Class II recall, which the FDA defines as “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.”
For daily wellness updates, subscribe to The Healthy newsletter and follow The Healthy on Facebook and Instagram. Keep reading: