Acella Pharmaceuticals recalls

Acella Pharmaceuticals appears in 16 official U.S. recall notices indexed by RecallRadar, most recently on 2026-05-13.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• 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 · 2026-05-13 · Acella Pharmaceuticals
  Reason: Chemical contamination; presence of lead and lithium above specification
• 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
  Reason: Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
• 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
  Reason: Subpotent drug
• 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
  Reason: Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
• 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
  Reason: Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
• 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
  Reason: Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
• NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta…
  FDA Drug · Class I · 2021-06-02 · Acella Pharmaceuticals
  Reason: Subpotent Drug
• NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA…
  FDA Drug · Class I · 2021-06-02 · Acella Pharmaceuticals
  Reason: Subpotent Drug
• NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192…
  FDA Drug · Class I · 2021-06-02 · Acella Pharmaceuticals
  Reason: Subpotent Drug
• NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and b) 7-count bottles (NDC 42192…
  FDA Drug · Class I · 2021-06-02 · Acella Pharmaceuticals
  Reason: Subpotent Drug
• NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 42192…
  FDA Drug · Class I · 2021-06-02 · Acella Pharmaceuticals
  Reason: Subpotent Drug
• NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta,…
  FDA Drug · Class I · 2020-10-28 · Acella Pharmaceuticals
  Reason: Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
• NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta,…
  FDA Drug · Class I · 2020-10-28 · Acella Pharmaceuticals
  Reason: Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
• NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharet…
  FDA Drug · Class I · 2020-06-10 · Acella Pharmaceuticals
  Reason: Superpotent Drug.
• NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta…
  FDA Drug · Class I · 2020-06-10 · Acella Pharmaceuticals
  Reason: Superpotent Drug.
• NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alph…
  FDA Drug · Class I · 2020-06-10 · Acella Pharmaceuticals
  Reason: Superpotent Drug.