← FDA ENFORCEMENT
D-0523-2026Class II

Acella Pharmaceuticals, LLC

Recalling firm
Acella Pharmaceuticals, LLC
Product type
Drug
Status
Ongoing
Report date
2026-05-13
Distribution
Nationwide
Firm state
GA
Product quantity
6,336 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Chemical contamination; presence of lead and lithium above specification

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

Code / lot info

Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IFrutas y Hortalizas del Sur S.A.2026-07-22Class IIGELLERT GLOBAL GROUP2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.