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Acella Pharmaceuticals, LLC

Acella Pharmaceuticals, LLC Recalls

All product recalls associated with Acella Pharmaceuticals, LLC.

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Recall Summary

Total Recalls

1000

Past Year

303

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1461–1480 of 4747 recalls

NP Thyroid 120 (Acella Pharmaceuticals) – Subpotent Medication (2020)

Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.

Class IHigh

FDASep 17, 2020Nationwide• Acella Pharmaceuticals, LLC

Nymalize (Arbor Pharmaceuticals) – Subpotent Drug (2020)

Subpotent Drug

Class IIILow

FDASep 16, 2020Nationwide• Arbor Pharmaceuticals Inc.

Citalopram Oral Solution (PAI Holdings) – Impurity Specification Failure (2020)

Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint

Class III

1...72 737475 76...238

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Low

FDASep 9, 2020Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Buprenorphine Transdermal System (Teva) – Stability Specification Failure (2020)

Failed Stability Specifications: Below specification result for buprenorphine release rate.

Class IIModerate

FDASep 4, 2020Nationwide• Teva Pharmaceuticals USA

Nature-Throid 1 Grain (Preferred Pharmaceuticals) – CGMP Deviation (2020)

CGMP Deviations

Class IIModerate

FDASep 2, 2020CA, GA, IN• Preferred Pharmaceuticals, Inc.

Nature-Throid 1/2 Grain (Preferred Pharmaceuticals) – CGMP Deviation (2020)

CGMP Deviations

Class IIModerate

FDASep 2, 2020CA, GA, IN• Preferred Pharmaceuticals, Inc.

Nature-Throid 1.5 Grain (Preferred Pharmaceuticals) – CGMP Deviation (2020)

CGMP Deviations

Class IIModerate

FDASep 2, 2020CA, GA, IN• Preferred Pharmaceuticals, Inc.

Nature-Throid 3/4 Grain (Preferred Pharmaceuticals) – CGMP Deviation (2020)

CGMP Deviations

Class IIModerate

FDASep 2, 2020CA, GA, IN• Preferred Pharmaceuticals, Inc.

Roche Diagnostics Operations, Inc.: BenchMark ULTRA Advanced Staining System (IVD)- Material ...

Fire/Burn Risk

Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket

FDAAug 31, 2020Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: DISCOVERY ULTRA Advanced Staining System (RUO-Research Us...

Fire/Burn Risk

FDAAug 31, 2020Nationwide• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics Inc: Siemens epoc BGEM Test Card-In vitro diagnostic device fo...

Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.

FDAAug 28, 2020Nationwide• Siemens Healthcare Diagnostics Inc

Roche Diagnostics Operations, Inc.: Tina-quant Complement C4 ver.2, Catalog 05991994190

Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

FDAAug 27, 2020Nationwide• Roche Diagnostics Operations, Inc.

Birch Sweet Essential Oil (Mystic Moments) – Packaging Safety (2020)

This recall involves 50 mL Mystic Moments Birch Sweet Essential Oil in amber glass bottles with black continuous thread closures. The blue label includes the product name and the volume size of the bottle.

CPSCAug 27, 2020Nationwide• Mystic Moments UK, of United Kingdom

Roche Diagnostics Operations, Inc.: Albumin Gen.2, Catalog 05166861190

FDAAug 27, 2020Nationwide• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc: Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog N...

Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results.

FDAAug 25, 2020Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc.: Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex ...

Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L). The low outlier results are generated from the last five (5) tests of the well

FDAAug 25, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.