Warning
Acella Pharmaceuticals Recalls NAPROXEN ORAL SUSPENSION
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0523-2026Drug / Pharmaceutical
Acella Pharmaceuticals Recalls NAPROXEN ORAL SUSPENSION
Acella Pharmaceuticals, LLC · Class II — Moderate Risk
Product Description
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
Reason for Recall
Chemical contamination; presence of lead and lithium above specification
FDA Classification
Class II — Moderate Risk
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.
Distribution
Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Acella Pharmaceuticals, LLC initiated the recall on April 20, 2026 affecting 6,336 bottles. Chemical contamination; presence of lead and lithium above specification. The product was distributed nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Acella Pharmaceuticals, LLC for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.