April 2026 FDA Recall Naproxen by Acella Pharmaceuticals, Llc
D-0523-2026 - Chemical contamination; presence of lead and lithium above specification
This Class II drug recall was voluntarily initiated by Acella Pharmaceuticals, Llc on April 20, 2026 for the product Naproxen. The FDA reported the reason for recall as chemical contamination; presence of lead and lithium above specification. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0523-2026
Chemical contamination; presence of lead and lithium above specification
04-20-2026
05-13-2026
6,336 bottles
Recall Profile & Regulatory Data
Class II - 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Acella Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
