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Jubilant Cadista Pharmaceuticals, Inc.

Jubilant Cadista Pharmaceuticals, Inc. Recalls

All product recalls associated with Jubilant Cadista Pharmaceuticals, Inc..

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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 1421–1440 of 4747 recalls

Clomipramine Capsules (Jubilant) – Specification Failure (2020)

Failed Tablet/Capsule Specification

Class IIModerate

FDANov 6, 2020Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Roche Diagnostics Operations, Inc.: Tina-quant C-Reactive Protein Gen.3, Catalog number 05172...

Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

FDANov 6, 2020Nationwide• Roche Diagnostics Operations, Inc.

VEO DIAGNOSTICS, LLC: ACCEL ELISA COVID-19 for the detection of total antibodie...

Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests

1...70 717273 74...238

Page 72 of 238Next

FDANov 5, 2020Nationwide• VEO DIAGNOSTICS, LLC

Sodium Chloride Injection (Hikma) – pH Specification (2020)

Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.

Class IIModerate

FDANov 3, 2020Nationwide• Hikma Pharmaceuticals USA Inc.

Metformin Tablets (Preferred) – NDMA Contamination (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Class IIModerate

FDANov 1, 2020FL, IN• Preferred Pharmaceuticals, Inc.

Mesalamine Tablets (Teva) – Dissolution Failure (2020)

Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.

Class IIModerate

FDAOct 28, 2020Nationwide• Teva Pharmaceuticals USA

Lansoprazole ODT (Zydus) – Dissolution Failure (2020)

Failed Dissolution Specification

Class IIModerate

FDAOct 27, 2020Nationwide• Zydus Pharmaceuticals (USA) Inc

Lansoprazole ODT (Zydus) – Dissolution Failure (2020)

Failed Dissolution Specification

Class IIModerate

FDAOct 27, 2020Nationwide• Zydus Pharmaceuticals (USA) Inc

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer - Product Usage: automated, imm...

Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values

FDAOct 26, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer - Product Usage: automated, imm...

Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values

FDAOct 26, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Olanzapine ODT (Jubilant) – Subpotent Medication (2020)

Subpotent

Class IIILow

FDAOct 26, 2020Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Hydrocodone-Acetaminophen (Ascent) – Foreign Tablet (2020)

Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.

Class IIModerate

FDAOct 26, 2020Nationwide• Ascent Pharmaceuticals, Inc.

Hardy Diagnostics: Viral Transport Medium, 3ml, Ref: R99, Container type: Tu...

There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing.

FDAOct 23, 2020Nationwide• Hardy Diagnostics

Felodipine Extended Release 10mg (Heritage) – Impurity Specifications (2020)

Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A

Class IIILow

FDAOct 23, 2020Nationwide• Heritage Pharmaceuticals 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

FDAOct 16, 2020Nationwide• Ortho Clinical Diagnostics 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.

Dextroamphetamine Mixture (ANI) – Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Class IIILow

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

Dextroamphetamine Saccharate (ANI Pharmaceuticals) - Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Class IIILow

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

Dextroamphetamine Saccharate (ANI Pharmaceuticals) - Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Class IIILow

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.

Dextroamphetamine Saccharate (ANI Pharmaceuticals) - Incorrect Expiration Date (2020)

Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.

Class IIILow

FDAOct 9, 2020Nationwide• ANI Pharmaceuticals, Inc.