Naproxen Oral Suspension Recalled Due to Chemical Contamination
Key Takeaways:
- The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for naproxen oral suspension, USP, 125 mg/5mL. The affected batches have been identified as Lot 23F02 (expires May 2026) and Lot 25A37 (expires January 2028), affecting 6336 bottles.
- The recall was initiated by Acella Pharmaceuticals due to an excessive amount of lead and lithium, a quality issue that may cause temporary or medically reversible adverse health consequences.
- Naproxen oral suspension is a prescription medication used to ease swelling and inflammation from arthritis and gout and can also reduce pain caused by headaches, tendonitis, and muscle cramps.
The FDA has issued a Class II recall for naproxen oral suspension, USP, 125 mg/5mL, affecting 6336 bottles. This medication is distributed nationwide, and recalled, by Acella Pharmaceuticals, LLC in Alpharetta, Georgia. The recall was initiated on April 20, 2026, and received a Class II classification on May 6, 2026.
The recall was initiated due to unsafe levels of lead and lithium in the product, particularly in Lot 23F02 and Lot 25A37, which expire in May 2026 and January 2028, respectively. A Class II classification means the use of this product may cause temporary or medically reversible adverse health consequences, and the probability of serious adverse health consequences is low. Acella Pharmaceuticals sent out a public notice via letter; no public press release has been issued for this recall.
Naproxen oral suspension is an anti-inflammatory drug used to reduce symptoms of arthritis and gout such as pain, swelling, and joint stiffness. It can also provide relief for headaches, dental pain, tendonitis, and menstrual cramps. Pharmacists should identify and quarantine Lots 23F02 and 25A37, remove them from inventory, and coordinate with prescribers to provide an alternative supply.
Reference
FDA. Enforcement Report. May 13, 2026. Accessed May 13, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219776
