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Jubilant Cadista Pharmaceuticals Recalls
31 recalls on record · May 8, 2013 to January 11, 2023 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 11, 2023DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Mary
Hazard: Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
August 3, 2022DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, Indi
Hazard: Failed Dissolution Specifications
August 3, 2022DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, Ind
Hazard: Failed dissolution specifications.
April 13, 2022DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. S
Hazard: Subpotent
April 6, 2022DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured
Hazard: Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
September 8, 2021DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by:
Hazard: Subpotent
April 21, 2021DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, Ind
Hazard: Failed Dissolution Specifications
March 10, 2021DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, In
Hazard: Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
December 2, 2020DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceutic
Hazard: Failed Tablet/Capsule Specification
November 11, 2020DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubila
Hazard: Subpotent
June 3, 2020DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., S
Hazard: Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
March 25, 2020DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd
Hazard: CGMP Deviations: Presence of dark brown discoloration on edges of tablets
December 18, 2019DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-24
Hazard: Presence of Foreign Substance: Presence of a foreign object in a single tablet.
October 23, 2019DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant
Hazard: CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
August 7, 2019DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each bl
Hazard: Failed dissolution specifications : failed results at the 3-month stability time point.
April 10, 2019DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics L
Hazard: Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
March 13, 2019DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59
Hazard: Failed Dissolution Specifications; 9-monthstability timepoint
October 17, 2018DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics L
Hazard: Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
September 26, 2018DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury,
Hazard: Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
August 29, 2018DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, M
Hazard: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
August 29, 2018DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, M
Hazard: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
August 29, 2018DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Ma
Hazard: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
August 29, 2018DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Ma
Hazard: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
June 13, 2018DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Mark
Hazard: Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
November 22, 2017DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmace
Hazard: Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
April 19, 2017DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) a
Hazard: Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
April 19, 2017DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) a
Hazard: Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
April 19, 2017DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) a
Hazard: Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
December 21, 2016DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc.
Hazard: 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.
August 6, 2014DrugsFDA
Jubilant Cadista Pharmaceuticals Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: J
Hazard: Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.