Home / Recalls / Acella Pharmaceuticals, LLC / D-0523-2026

D-0523-2026 Class II Ongoing

Recalled by Acella Pharmaceuticals, LLC — Alpharetta, GA

Recall Details

Product Type
Drugs
Report Date
May 13, 2026
Initiation Date
April 20, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,336 bottles

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

Reason for Recall

Chemical contamination; presence of lead and lithium above specification

Distribution Pattern

Nationwide

Code Information

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

Other recalls by Acella Pharmaceuticals, LLC

  • D-0014-2026 Class II — Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed (September 29, 2025)
  • D-0490-2024 Class III — Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, M (April 24, 2024)
  • D-0074-2023 Class III — Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing (November 14, 2022)
  • D-0069-2023 Class III — Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x (November 14, 2022)
  • D-0070-2023 Class III — Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x (November 14, 2022)
  • D-0399-2021 Class I — NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count b (April 29, 2021)
  • D-0397-2021 Class I — NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Ma (April 29, 2021)
  • D-0396-2021 Class I — NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count b (April 29, 2021)
  • D-0398-2021 Class I — NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx onl (April 29, 2021)
  • D-0395-2021 Class I — NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count b (April 29, 2021)