Acella Pharmaceuticals recalls
FDA enforcement reports naming Acella Pharmaceuticals, LLC as the recalling firm.
- Recall reports
- 16
- Class I (serious)
- 10
- Most recent report
- May 13, 2026
- May 13, 2026NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distribut…Drug · Acella Pharmaceuticals, LLCChemical contamination; presence of lead and lithium above specificationClass II
- Oct 15, 2025Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Ac…Drug · Acella Pharmaceuticals, LLCFailed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.Class II
- May 15, 2024Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170Drug · Acella Pharmaceuticals, LLCSubpotent drugClass III
- Dec 7, 2022Sodium Sulfacetamide 10% Sulfur 4% Cleansing PadsDrug · Acella Pharmaceuticals, LLCSubpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.Class III
- Nov 30, 2022Phenytoin Sodium Injection, USP 100 mg/2 mLDrug · Acella Pharmaceuticals, LLCLabeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.Class III
- Nov 30, 2022Phenytoin Sodium Injection, USP, 250 mg/5 mLDrug · Acella Pharmaceuticals, LLCLabeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.Class III
- Jun 2, 2021NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manu…Drug · Acella Pharmaceuticals, LLCSubpotent DrugClass I
- Jun 2, 2021NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles…Drug · Acella Pharmaceuticals, LLCSubpotent DrugClass I
- Jun 2, 2021NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactu…Drug · Acella Pharmaceuticals, LLCSubpotent DrugClass I
- Jun 2, 2021NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles…Drug · Acella Pharmaceuticals, LLCSubpotent DrugClass I
- NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles…
- NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manuf…
- NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufa…
- NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Man…
- NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manuf…
- NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only,…
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