NAPROXEN ORAL SUSPENSION — Class II drug recall D-0523-2026
Ongoing recall by Acella Pharmaceuticals, LLC, reported 2026-05-13, distributed nationwide. Chemical contamination; presence of lead and lithium above specification
| Recall number | D-0523-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acella Pharmaceuticals, LLC, Alpharetta, GA, United States |
| Recall initiated | 2026-04-20 |
| Classified | 2026-05-06 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 6,336 bottles |
| Reason classes | chemical contamination |
| NDC | 42192-0619, 42192-0619-16 |
| Lot numbers | 23F02, 25A37 |
| Expiration dates | 2026-05, 2028-01 |
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
Reason for recall
Chemical contamination; presence of lead and lithium above specification
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0523-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.