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Jubilant Cadista Pharmaceuticals, Inc.
Jubilant Cadista Pharmaceuticals, Inc.: 31 FDA recall reports
Every drug recall the FDA has published for Jubilant Cadista Pharmaceuticals, Inc.. The fault, and how the agency graded it.
31Reports
2Class I
0Ongoing
2023-01-11Most recent
2 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salis
D-0096-2023 · Class III · reported 2023-01-11 · Terminated
- Why it was recalled
- Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
- Product
- Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
- Where it went
- Nationwide in the USA.
- How much
- 14,061 bottles
Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 24
D-1294-2022 · Class II · reported 2022-08-03 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90
- Where it went
- Nationwide within the United States
- How much
- 28,560 bottles
Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 2
D-1293-2022 · Class II · reported 2022-08-03 · Terminated
- Why it was recalled
- Failed dissolution specifications.
- Product
- Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90
- Where it went
- Nationwide within the United States
- How much
- 9,600 bottles
Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceutic
D-0752-2022 · Class III · reported 2022-04-13 · Terminated
- Why it was recalled
- Subpotent
- Product
- Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 19,222 Bottles (100-count)
Class I
Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Ma
D-0767-2022 · Class I · reported 2022-04-06 · Terminated
- Why it was recalled
- 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
- Product
- Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06
- Where it went
- Product was distributed in Arkansas, Florida, North Carolina, South Carolina and Ohio.
- How much
- 12,174 bottles
Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Mar
D-0784-2021 · Class III · reported 2021-09-08 · Terminated
- Why it was recalled
- Subpotent
- Product
- Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90
- Where it went
- Product was distributed nationwide.
- How much
- 14,544 bottles
Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 2
D-0333-2021 · Class II · reported 2021-04-21 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30.
- Where it went
- Nationwide in the USA
- How much
- Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles)
Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceu
D-0298-2021 · Class III · reported 2021-03-10 · Terminated
- Why it was recalled
- Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
- Product
- Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03
- Where it went
- USA nationwide, including Puerto Rico.
- How much
- 635,400 cartons
clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Ph
D-0104-2021 · Class II · reported 2020-12-02 · Terminated
- Why it was recalled
- Failed Tablet/Capsule Specification
- Product
- clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30
- Where it went
- Product was distributed nationwide.
- How much
- 4,416 bottles
Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured
D-0066-2021 · Class III · reported 2020-11-11 · Terminated
- Why it was recalled
- Subpotent
- Product
- Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32
- Where it went
- Product was distributed nationwide
- How much
- 23,616 blister packs
Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceutica
D-1281-2020 · Class III · reported 2020-06-03 · Terminated
- Why it was recalled
- Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
- Product
- Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97.
- Where it went
- TN
- How much
- 1,313,333 tablets
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Ge
D-1058-2020 · Class II · reported 2020-03-25 · Terminated
- Why it was recalled
- CGMP Deviations: Presence of dark brown discoloration on edges of tablets
- Product
- Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90
- Where it went
- Distributed Nationwide in the USA
- How much
- 89,376 90-count bottles
Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd.,
D-0576-2020 · Class II · reported 2019-12-18 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Presence of a foreign object in a single tablet.
- Product
- Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01.
- Where it went
- Nationwide in the USA.
- How much
- 1,824 bottles
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by
D-0145-2020 · Class II · reported 2019-10-23 · Terminated
- Why it was recalled
- CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
- Product
- Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90
- Where it went
- Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level.
- How much
- 63,216 bottles
Class I
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister car
D-1837-2019 · Class I · reported 2019-08-07 · Terminated
- Why it was recalled
- Failed dissolution specifications : failed results at the 3-month stability time point.
- Product
- Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43
- Where it went
- USA Nationwide
- How much
- 11,412 cartons/34,236 blister cards/28 tablets each card
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant
D-1074-2019 · Class II · reported 2019-04-10 · Terminated
- Why it was recalled
- Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
- Product
- Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
- Where it went
- Nationwide in the USA.
- How much
- 12,960 bottles
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 cou
D-0519-2019 · Class III · reported 2019-03-13 · Terminated
- Why it was recalled
- Failed Dissolution Specifications; 9-monthstability timepoint
- Product
- BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD
- Where it went
- Product was distributed to one customer who may have further distributed the product.
- How much
- a) 3,072 bottles; b) 2,688 bottles
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant
D-0011-2019 · Class II · reported 2018-10-17 · Terminated
- Why it was recalled
- Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
- Product
- Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
- Where it went
- Product was distributed Nationwide in the USA and Puerto Rico.
- How much
- 158,466 bottles
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc.
D-1205-2018 · Class III · reported 2018-09-26 · Terminated
- Why it was recalled
- Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
- Product
- MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
- Where it went
- Product was distributed throughout the United States.
- How much
- 89,722 blister pack
Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 024766
D-1106-2018 · Class III · reported 2018-08-29 · Terminated
- Why it was recalled
- Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- Product
- Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90
- Where it went
- Product was distributed throughout the United States to wholesalers and retailers.
- How much
- 7,048 bottles
Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661
D-1103-2018 · Class III · reported 2018-08-29 · Terminated
- Why it was recalled
- Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- Product
- Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30
- Where it went
- Product was distributed throughout the United States to wholesalers and retailers.
- How much
- 10,577 bottles
Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661
D-1104-2018 · Class III · reported 2018-08-29 · Terminated
- Why it was recalled
- Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- Product
- Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90
- Where it went
- Product was distributed throughout the United States to wholesalers and retailers.
- How much
- 9,552 bottles
Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 024766
D-1105-2018 · Class III · reported 2018-08-29 · Terminated
- Why it was recalled
- Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- Product
- Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-362-90
- Where it went
- Product was distributed throughout the United States to wholesalers and retailers.
- How much
- 18,947 bottles
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, I
D-0876-2018 · Class III · reported 2018-06-13 · Terminated
- Why it was recalled
- Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
- Product
- Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
- Where it went
- IN, MI, MS, NC, NJ, NY and OH
- How much
- 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadist
D-0082-2018 · Class III · reported 2017-11-22 · Terminated
- Why it was recalled
- Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
- Product
- Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
- Where it went
- Nationwide
- How much
- 744 bottles
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746
D-0670-2017 · Class III · reported 2017-04-19 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
- Product
- BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
- Where it went
- Nationwide in the USA
- How much
- 81,077 bottles
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746
D-0669-2017 · Class III · reported 2017-04-19 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
- Product
- BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
- Where it went
- Nationwide in the USA
- How much
- 20,882 bottles
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746
D-0671-2017 · Class III · reported 2017-04-19 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
- Product
- BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
- Where it went
- Nationwide in the USA
- How much
- 19,682 bottles
Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceut
D-0205-2017 · Class III · reported 2016-12-21 · Terminated
- Why it was recalled
- 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.
- Product
- Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14.
- Where it went
- Nationwide and Puerto Rico.
- How much
- 1512 bottles
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufact
D-1500-2014 · Class II · reported 2014-08-06 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
- Product
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90
- Where it went
- Nationwide and Puerto Rico
- How much
- 9,358 bottles
Showing the 30 most recent of 31. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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