Alpharetta, GA, United States
Acella Pharmaceuticals, LLC recalls
8 recalls recorded since 2018, most recently on 20 April 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)2
Terminated or completed6
Class I (FDA)3
Ongoing Class II Drugs
- Recall started
- 20 April 2026
- Reason
- Chemical contamination; presence of lead and lithium above specification
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0523-2026
- 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
Ongoing Class II Drugs
- Recall started
- 29 September 2025
- Reason
- Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0014-2026
- Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
Terminated Class III Drugs
- Recall started
- 24 April 2024
- Terminated
- 22 December 2025
- Reason
- Subpotent drug
- Distribution
- Nationwide in the US and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0490-2024
- Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06
Terminated Class III Drugs
- Recall started
- 14 November 2022
- Terminated
- 1 August 2024
- Reason
- Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0074-2023
- Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60
Terminated Class III Drugs
- Recall started
- 14 November 2022
- Terminated
- 21 August 2024
- Reason
- Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0070-2023, D-0069-2023
- 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, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
- 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, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Terminated Class I Drugs
- Recall started
- 29 April 2021
- Terminated
- 13 March 2024
- Reason
- Subpotent Drug
- Distribution
- Nationwide within the United States including Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0399-2021, D-0396-2021, D-0397-2021, D-0398-2021, D-0395-2021
- 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 42192-328-07) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30
- 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 42192-329-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 3
- NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-330-01
- NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-331-01
- 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 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 3
Terminated Class I Drugs
- Recall started
- 17 September 2020
- Terminated
- 8 December 2022
- Reason
- Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0035-2021, D-0036-2021
- NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01
- NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-328-01
Terminated Class I Drugs
- Recall started
- 22 May 2020
- Terminated
- 19 January 2022
- Reason
- Superpotent Drug.
- Distribution
- Distributed Nationwide in the US and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1299-2020, D-1298-2020, D-1300-2020
- NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-330-01.
- NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-329-01.
- NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-331-01.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.