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Nostrum Laboratories Inc

Nostrum Laboratories Inc Recalls

All product recalls associated with Nostrum Laboratories Inc.

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Recall Summary

Total Recalls

970

Past Year

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 361–380 of 970 recalls

Metformin HCL Extended-Release 750mg (Nostrum) – NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAOct 23, 2020Nationwide• Nostrum Laboratories Inc

Metformin HCL Extended-Release 500mg (Nostrum) – NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAOct 23, 2020Nationwide• Nostrum Laboratories Inc

Ortho Clinical Diagnostics Inc: VITROS Chemistry Products Performance Verifier II-For in ...

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

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FDAOct 16, 2020Nationwide• Ortho Clinical Diagnostics Inc

Avanos Medical, Inc.: CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV C...

Detachment of the Male AIV Adaptor from the Y-Connector.

FDAOct 16, 2020CA, CO, IL +3 more• Avanos Medical, Inc.

Roche Diagnostics Operations, Inc.: cobas infinity central lab/cobas infinity core license-Th...

Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule

FDAOct 9, 2020Nationwide• Roche Diagnostics Operations, Inc.

Hardy Diagnostics: Strep B Carrot Broth One-Step, Ref. Z40, UDI: 0081939802...

Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10

FDAOct 6, 2020AL, AK, AZ +18 more• Hardy Diagnostics

Epitope Diagnostics, Inc.: EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-103...

The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.

FDAOct 1, 2020CA, CO, FL +17 more• Epitope Diagnostics, Inc.

Ortho Clinical Diagnostics Inc: VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrato...

Laceration Risk

Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control

FDASep 30, 2020Nationwide• Ortho Clinical Diagnostics Inc

Siemens Healthcare Diagnostics, Inc.: Atellica CH Systems Fructosamine (FRUC)-For in vitro diag...

Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.

FDASep 22, 2020CA, DE, MD +4 more• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro ...

FDASep 22, 2020CA, DE, MD +4 more• Siemens Healthcare Diagnostics, 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.

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.

Roche Diagnostics Operations, Inc.: Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602...

Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.

FDAAug 20, 2020Nationwide• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension LOCI High Sensitivity Troponin I (TNIH) Flex re...

Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed

FDAAug 19, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Avanos Medical, Inc.: AVANOS MIC-KEY SF Gastrostomy Feeding Tube

Devices had cracked or detached from the feeding tube body

FDAJul 29, 2020IL, LA, NJ +4 more• Avanos Medical, Inc.