Jubilant Cadista Pharmaceuticals recalls

Jubilant Cadista Pharmaceuticals appears in 31 official U.S. recall notices indexed by RecallRadar, most recently on 2023-01-11.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 597…
  FDA Drug · Class III · 2023-01-11 · Jubilant Cadista Pharmaceuticals
  Reason: Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
• Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd
  FDA Drug · Class II · 2022-08-03 · Jubilant Cadista Pharmaceuticals
  Reason: Failed Dissolution Specifications
• Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd
  FDA Drug · Class II · 2022-08-03 · Jubilant Cadista Pharmaceuticals
  Reason: Failed dissolution specifications.
• Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc
  FDA Drug · Class III · 2022-04-13 · Jubilant Cadista Pharmaceuticals
  Reason: Subpotent
• Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadis…
  FDA Drug · Class I · 2022-04-06 · Jubilant Cadista Pharmaceuticals
  Reason: 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 Hydroc…
• Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd
  FDA Drug · Class III · 2021-09-08 · Jubilant Cadista Pharmaceuticals
  Reason: Subpotent
• Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India
  FDA Drug · Class II · 2021-04-21 · Jubilant Cadista Pharmaceuticals
  Reason: Failed Dissolution Specifications
• Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 2…
  FDA Drug · Class III · 2021-03-10 · Jubilant Cadista Pharmaceuticals
  Reason: Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
• clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury…
  FDA Drug · Class II · 2020-12-02 · Jubilant Cadista Pharmaceuticals
  Reason: Failed Tablet/Capsule Specification
• Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd.,…
  FDA Drug · Class III · 2020-11-11 · Jubilant Cadista Pharmaceuticals
  Reason: Subpotent
• Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801,…
  FDA Drug · Class III · 2020-06-03 · Jubilant Cadista Pharmaceuticals
  Reason: Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
• Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 In…
  FDA Drug · Class II · 2020-03-25 · Jubilant Cadista Pharmaceuticals
  Reason: CGMP Deviations: Presence of dark brown discoloration on edges of tablets
• Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India
  FDA Drug · Class II · 2019-12-18 · Jubilant Cadista Pharmaceuticals
  Reason: Presence of Foreign Substance: Presence of a foreign object in a single tablet.
• Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roor…
  FDA Drug · Class II · 2019-10-23 · Jubilant Cadista Pharmaceuticals
  Reason: CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
• Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains…
  FDA Drug · Class I · 2019-08-07 · Jubilant Cadista Pharmaceuticals
  Reason: Failed dissolution specifications : failed results at the 3-month stability time point.
• Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 2476…
  FDA Drug · Class II · 2019-04-10 · Jubilant Cadista Pharmaceuticals
  Reason: Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
• BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles…
  FDA Drug · Class III · 2019-03-13 · Jubilant Cadista Pharmaceuticals
  Reason: Failed Dissolution Specifications; 9-monthstability timepoint
• Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 2476…
  FDA Drug · Class II · 2018-10-17 · Jubilant Cadista Pharmaceuticals
  Reason: Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
• MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack
  FDA Drug · Class III · 2018-09-26 · Jubilant Cadista Pharmaceuticals
  Reason: Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
• Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant…
  FDA Drug · Class III · 2018-08-29 · Jubilant Cadista Pharmaceuticals
  Reason: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
• Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilan…
  FDA Drug · Class III · 2018-08-29 · Jubilant Cadista Pharmaceuticals
  Reason: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
• Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant…
  FDA Drug · Class III · 2018-08-29 · Jubilant Cadista Pharmaceuticals
  Reason: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
• Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilan…
  FDA Drug · Class III · 2018-08-29 · Jubilant Cadista Pharmaceuticals
  Reason: Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
• Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd
  FDA Drug · Class III · 2018-06-13 · Jubilant Cadista Pharmaceuticals
  Reason: Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
• Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salis…
  FDA Drug · Class III · 2017-11-22 · Jubilant Cadista Pharmaceuticals
  Reason: Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
• BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bot…
  FDA Drug · Class III · 2017-04-19 · Jubilant Cadista Pharmaceuticals
  Reason: Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
• BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bot…
  FDA Drug · Class III · 2017-04-19 · Jubilant Cadista Pharmaceuticals
  Reason: Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
• BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bot…
  FDA Drug · Class III · 2017-04-19 · Jubilant Cadista Pharmaceuticals
  Reason: Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
• Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 218…
  FDA Drug · Class III · 2016-12-21 · Jubilant Cadista Pharmaceuticals
  Reason: 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.
• Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pha…
  FDA Drug · Class II · 2014-08-06 · Jubilant Cadista Pharmaceuticals
  Reason: Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
• Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India…
  FDA Drug · Class II · 2013-05-08 · Jubilant Cadista Pharmaceuticals
  Reason: cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.