Acella Pharmaceuticals, LLC

Complete recall history across all FDA and CPSC categories — 15 total recalls

Acella Pharmaceuticals, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (15)

FDA drug safety enforcement actions by Acella Pharmaceuticals, LLC

Date Product Reason Class
Sep 29, 2025 Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distribu... Failed dissolution specifications: Stability testing found that the lot did n... Class II
Apr 24, 2024 Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle... Subpotent drug Class III
Nov 14, 2022 Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10... Labeling: Not elsewhere classified; the product is being recalled because of ... Class III
Nov 14, 2022 Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 1... Labeling: Not elsewhere classified; the product is being recalled because of ... Class III
Nov 14, 2022 Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleans... Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-mo... Class III
Apr 29, 2021 NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-coun... Subpotent Drug Class I
Apr 29, 2021 NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx ... Subpotent Drug Class I
Apr 29, 2021 NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only... Subpotent Drug Class I
Apr 29, 2021 NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-coun... Subpotent Drug Class I
Apr 29, 2021 NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-coun... Subpotent Drug Class I
Sep 17, 2020 NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx O... Subpotent Drug: FDA analysis found these products to be less than the labeled... Class I
Sep 17, 2020 NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx On... Subpotent Drug: FDA analysis found these products to be less than the labeled... Class I
May 22, 2020 NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles... Superpotent Drug. Class I
May 22, 2020 NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx... Superpotent Drug. Class I
May 22, 2020 NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx O... Superpotent Drug. Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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