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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

Past Year

Class I (Serious)

Most Recent

Dec 2022

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 21–31 of 31 recalls

Valsartan Tablets 40mg (Jubilant Cadista) – incorrect excipient (2018)

Undeclared Allergen

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

Class IIILow

FDAAug 14, 2018Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Valsartan Tablets (Jubilant Cadista) – Incorrect Excipient (2018)

Undeclared Allergen

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

Class IIILow

FDAAug 14, 2018Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Valsartan Tablets (Jubilant Cadista) – Incorrect Excipient (2018)

Page 2 of 2Next

Undeclared Allergen

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

Class IIILow

FDAAug 14, 2018Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Valsartan Tablets USP (Jubilant Cadista) – Incorrect Excipient (2018)

Undeclared Allergen

Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).

Class IIILow

FDAMay 25, 2018IN, MI, MS +4 more• Jubilant Cadista Pharmaceuticals, Inc.

Meclizine Tablets (Jubilant Cadista) – Unapproved Marketing (2017)

Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.

Class IIILow

FDAOct 30, 2017Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Methylprednisolone Tablets (Jubilant Cadista) – incorrect expiration date (2016)

Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.

Class IIILow

FDAJun 13, 2016Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

BuPROPion Extended-release 200mg (Jubilant) – Impurity Specs (2016)

Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

Class IIILow

FDAApr 8, 2016Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

BuPROPion Extended-release 150mg (Jubilant) – Impurity Specs (2016)

Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

Class IIILow

FDAApr 8, 2016Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

BuPROPion Extended-release 100mg (Jubilant) – Impurity Specs (2016)

Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

Class IIILow

FDAApr 8, 2016Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Losartan Potassium Hydrochlorothiazide Tablets (Jubilant) – Metal Contamination (2014)

Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.

Class IIModerate

FDAJul 11, 2014Nationwide• Jubilant Cadista Pharmaceuticals Inc.

Pantoprazole Sodium Tablets (Jubilant) – Manufacturing Deviation (2013)

cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.

Class IIModerate

FDAFeb 11, 2013Nationwide• Jubilant Cadista Pharmaceuticals Inc.