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Acella Pharmaceuticals, LLC FDA Recalls
11 recalls on file across drugs, 5 of them Class I and 2 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLClass IIApr 20, 2026Chemical contamination; presence of lead and lithium above s |
| Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, AlpharClass IISep 29, 2025Failed dissolution specifications: Stability testing found t |
| Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LClass IIIApr 24, 2024Subpotent drug |
| Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30Class IIINov 14, 2022Labeling: Not elsewhere classified; the product is being rec |
| Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,)Class IIINov 14, 2022Subpotent drug: Out of specification for assay at the end-of |
| 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,Class IIINov 14, 2022Labeling: Not elsewhere classified; the product is being rec |
| NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-countClass IApr 29, 2021Subpotent Drug |
| NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-countClass IApr 29, 2021Subpotent Drug |
| NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals, Class IApr 29, 2021Subpotent Drug |
| NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella PharmaceuticClass IApr 29, 2021Subpotent 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-countClass IApr 29, 2021Subpotent Drug |