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Class II: temporary or reversible health riskOngoing

Acella Pharmaceuticals Naproxen Oral Suspension Recall

NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distribut…

Acella Pharmaceuticals, LLC · Alpharetta, GA

Risk level
Class II
Reported by FDA
May 13, 2026
Recall ID
D-0523-2026
Check your lot numberHow we source this data

Summary

Acella Pharmaceuticals recalled Naproxen Oral Suspension starting Apr 20, 2026. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0523-2026 on May 13, 2026. Reason: Chemical contamination; presence of lead and lithium above specification. Status: Ongoing.

Why it was recalled

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0523-2026
Classification
Class II
Status
Ongoing
Recall initiated
Apr 20, 2026
FDA report date
May 13, 2026
Quantity
6,336 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Acella Pharmaceuticals, LLC

Original FDA data

Every field from FDA enforcement report D-0523-2026, exactly as published.

Show all FDA fields
City
Alpharetta
State
GA
Status
Ongoing
Country
United States
Event ID
98781
Address
1880 Mcfarland Pkwy Ste 110
Code information
Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
Postal code
30005-1795
Report date
May 13, 2026
Product type
Drugs
Recall number
D-0523-2026
Classification
Class II
Recalling firm
Acella Pharmaceuticals, LLC
Product quantity
6,336 bottles
Reason for recall
Chemical contamination; presence of lead and lithium above specification
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Apr 20, 2026
Initial firm notification
Letter
Center classification date
May 6, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0523-2026, published May 13, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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