FDA Drug recall D-0523-2026
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 3…
- FDA Drug
- Class II
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class II recall of NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 3… by Acella Pharmaceuticals, citing chemical contamination; presence of lead and lithium above specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0523-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-20 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Acella Pharmaceuticals |
| Distribution | US |
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
Chemical contamination; presence of lead and lithium above specification
Identifiers
| ndc | 42192-619-16 |
|---|---|
| code_info | Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Acella Pharmaceuticals
- Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC…
FDA Drug · Class II · 2025-10-15 · Acella Pharmaceuticals - Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30…
FDA Drug · Class III · 2024-05-15 · Acella Pharmaceuticals - Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactu…
FDA Drug · Class III · 2022-12-07 · Acella Pharmaceuticals - Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufact…
FDA Drug · Class III · 2022-11-30 · Acella Pharmaceuticals - Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactu…
FDA Drug · Class III · 2022-11-30 · Acella Pharmaceuticals
All Acella Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0523-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.