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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 861–880 of 4747 recalls

Phenytoin Sodium Injection (Acella) – Missing Barcode (2022)

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Class IIILow

FDANov 14, 2022Nationwide• Acella Pharmaceuticals, LLC

9 Gauge Disposable Trocars (ENDO Pharmaceuticals) – No Expiration Dates (2022)

No expiration dates printed on the packaging

FDANov 8, 2022Nationwide• ENDO Pharmaceuticals Solutions, Inc.

IMMULITE 2000 Allergy IgE Kit (Siemens) – False Reactivity Risk (2022)

Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

1...42 434445 46...238

Page 44 of 238Next

FDA

Nov 4, 2022

Nationwide

• Siemens Healthcare Diagnostics, Inc.

Immulite Testosterone Assay (Siemens) – Positive Bias (2022)

Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to the IMMULITE 2000/IMMULITE 2000 XPi Total Testosterone Assay. Two (2) lots of Total Testosterone assays for the IMMULITE/IMMULITE 1000, kit lots #515 and #516 were actively distributed to customers when the issue was discovered by Siemens, and they are subject to the correction or removal in this recall (867 total quantity of reagents distributed for each lot). The violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. In both males and female, testosterone results are not used in isolation but are interpreted in conjunction with clinical history and symptomology as well as with other laboratory testing (e.g. gonadotropins and other sex steroids). A delay in the diagnosis may be experienced and medical intervention, such as repeat testing may be required.

FDAOct 25, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

eSuction Small Cavity (Endo-Therapeutics) – Regulatory Issue (2022)

Improper device regulatory classification

FDAOct 24, 2022FL, PA• Endo-Therapeutics, Inc.

Buprenorphine and Naloxone Sublingual Tablets (Sun Pharmaceutical) – Foreign Substance (2022)

Presence of Foreign Substance

Class IIModerate

FDAOct 18, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Accelerate PhenoTest BC Kit (Accelerate) – False Positive Risk (2022)

Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.

FDAOct 17, 2022AR, CA, FL +28 more• Accelerate Diagnostics Inc

Philips Laser System (Spectranetics) – System Failure Risk (2022)

Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is cleared. May result in initiation of treatment delay and/or treatment beyond initial scope and/or unable to treat patient.

FDAOct 14, 2022AZ, AR, CA +27 more• Spectranetics Corporation

VITROS Chemistry Calibrator (Ortho-Clinical) – Calibration Mathematics Issue (2022)

Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.

FDAOct 13, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

Flunisolide Nasal Solution (Ingenus) – substance impurity (2022)

Out of specification for related substances (impurities).

Class IIModerate

FDASep 30, 2022Nationwide• Ingenus Pharmaceuticals Llc

Atellica CH Lithium Test (Siemens) – False Results Risk (2022)

Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.

FDASep 19, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH Lithium Test (Siemens) – False Results Risk (2022)

FDASep 19, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Clonidine Hydrochloride Tablets (UNICHEM) – Product Mix-up (2022)

Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

Class IIILow

FDASep 19, 2022Nationwide• UNICHEM PHARMACEUTICALS USA INC

Neoral Cyclosporine Capsules (Novartis) – Ethanol Content Issue (2022)

CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.

Class IIModerate

FDASep 16, 2022Nationwide• Novartis Pharmaceuticals Corporation

Lisinopril Tablets (Lupin) – Foreign Substance Risk (2022)

Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.

Class IIModerate

FDASep 13, 2022Nationwide• Lupin Pharmaceuticals Inc.

Clip COVID Rapid Test (Clip Health) – Shelf Life Extension (2022)

COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.

FDASep 2, 2022Nationwide• LUMINOSTICS, INC dba CLIP HEALTH

BN II System Antiserum (Siemens) – Reagent Performance Issue (2022)

N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

FDAAug 30, 2022Nationwide• SIEMENS HEALTHCARE DIAGNOSTICS INC

BN ProSpec System Antiserum (Siemens) – Reagent Performance Issue (2022)

N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

FDAAug 30, 2022Nationwide• SIEMENS HEALTHCARE DIAGNOSTICS INC

ADHD Medication (Teva) – Strength Labeling Error (2022)

Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.

Class IIModerate

FDAAug 29, 2022Nationwide• Teva Pharmaceuticals USA Inc

Dimension Vista HDLC Test (Siemens) – Result Accuracy Problem (2022)

Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.

FDAAug 24, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.