Naproxen Suspension
FDA Recall NDC 42192-619
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Naproxen (NDC 42192-619). A significant event, classified as Class II, was initiated on Apr 20, 2026 by Acella Pharmaceuticals, Llc. The reported reason for this action was: "Chemical contamination; presence of lead and lithium above specification"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
April 2026 Class II Recall: Chemical contamination; presence of lead and lithium above specification
Recall Number
Class II Ongoing
Chemical contamination; presence of lead and lithium above specification
Apr 20, 2026
May 13, 2026
6,336 bottles
Recall Profile & Regulatory Data
Event ID
98781
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
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
Batch or Lot Expiration Information
Lot# Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
Affected Packages Involved in this Recall
42192-619-16Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
