FDA DrugsClass II
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Di...
Published: May 13, 2026Recall ID: D-0523-2026Category: drugsCountry: US
Reason for Recall / Hazard
Chemical contamination; presence of lead and lithium above specification
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Alpharetta |
| State | GA |
| Openfda › Nui › 1 | N0000000160 |
| Openfda › Nui › 2 | M0001335 |
| Openfda › Nui › 3 | N0000175722 |
| Openfda › Upc | 0342192619166 |
| Openfda › Unii | 57Y76R9ATQ |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 311913 |
| Openfda › Spl id | 47a98b71-a338-b13d-e063-6394a90a96f6 |
| Openfda › Brand name | NAPROXEN |
| Openfda › Spl set id | 7e6f03fb-4b36-4418-9684-f45637abbb78 |
| Openfda › Package ndc | 42192-619-16 |
| Openfda › Product ndc | 42192-619 |
| Openfda › Generic name | NAPROXEN |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Anti-Inflammatory Agents, Non-Steroidal [CS] |
| Openfda › Substance name | NAPROXEN |
| Openfda › Pharm class epc | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Openfda › Pharm class moa | Cyclooxygenase Inhibitors [MoA] |
| Openfda › Manufacturer name | Acella Pharmaceuticals, LLC |
| Openfda › Application number | NDA018965 |
| Openfda › Is original packager | true |
| Event id | 98781 |
| Address 1 | 1880 Mcfarland Pkwy Ste 110 |
| Code info | Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028. |
| Postal code | 30005-1795 |
| Report date | 20260513 |
| Product type | Drugs |
| Product quantity | 6,336 bottles |
| Reason for recall | Chemical contamination; presence of lead and lithium above specification |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260420 |
| Initial firm notification | Letter |
| Center classification date | 20260506 |
Overview
- Recalling FirmAcella Pharmaceuticals, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide