Acella Pharmaceuticals, LLC
2 ongoing recalls and 14 historical records
Based on the official records currently available to Public Health Trace, 2 recalls naming Acella Pharmaceuticals, LLC are currently shown as ongoing. The other 14 records below are historical.
Public Health Trace has 16 recalls naming Acella Pharmaceuticals, LLC as the recalling firm, republished from official FDA and USDA sources.
Recall records - 16 total Recalls by year
A bar chart of the number of recalls naming this company by year.
Recalls by year
Year Recalls 2020 5 2021 5 2022 3 2024 1 2025 1 2026 1
Download CSV FDA Recall
Ongoing 2026 record Class II
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 by Acella Pharmaceuticals, LLC
Reason
Chemical contamination; presence of lead and lithium above specification Published
May 13, 2026 Distribution
Nationwide
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FDA Recall
Ongoing Historical record Class II
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05. by Acella Pharmaceuticals, LLC
Reason
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. Published
October 15, 2025 Distribution
Nationwide
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FDA Recall
Terminated Terminated: December 22, 2025 Historical record Class III
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 by Acella Pharmaceuticals, LLC
Reason
Subpotent drug Published
May 15, 2024 Distribution
Nationwide
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FDA Recall
Terminated Terminated: August 1, 2024 Historical record Class III
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 by Acella Pharmaceuticals, LLC
Reason
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period. Published
December 7, 2022 Distribution
Nationwide
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FDA Recall
Terminated Terminated: August 21, 2024 Historical record Class III
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 by Acella Pharmaceuticals, LLC
Reason
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. Published
November 30, 2022 Distribution
Nationwide
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FDA Recall
Terminated Terminated: August 21, 2024 Historical record Class III
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 by Acella Pharmaceuticals, LLC
Reason
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. Published
November 30, 2022 Distribution
Nationwide
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FDA Recall
Terminated Terminated: March 13, 2024 Historical record Class I
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 by Acella Pharmaceuticals, LLC
Reason
Subpotent Drug Published
June 2, 2021 Distribution
Nationwide
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FDA Recall
Terminated Terminated: March 13, 2024 Historical record Class I
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 30005 by Acella Pharmaceuticals, LLC
Reason
Subpotent Drug Published
June 2, 2021 Distribution
Nationwide
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FDA Recall
Terminated Terminated: March 13, 2024 Historical record Class I
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 30005 by Acella Pharmaceuticals, LLC
Reason
Subpotent Drug Published
June 2, 2021 Distribution
Nationwide
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FDA Recall
Terminated Terminated: March 13, 2024 Historical record Class I
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 by Acella Pharmaceuticals, LLC
Reason
Subpotent Drug Published
June 2, 2021 Distribution
Nationwide
View recall →
FDA Recall
Terminated Terminated: March 13, 2024 Historical record Class I
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 30005 by Acella Pharmaceuticals, LLC
Reason
Subpotent Drug Published
June 2, 2021 Distribution
Nationwide
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FDA Recall
Terminated Terminated: December 8, 2022 Historical record Class I
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 by Acella Pharmaceuticals, LLC
Reason
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product. Published
October 28, 2020 Distribution
Nationwide
View recall →
Some FDA recall records on this page come from FDA's Enforcement Report database .
Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
This page lists recalls that name Acella Pharmaceuticals, LLC as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
Read the full medical disclaimer .
