Recall Register

Food, drugs, devices › Jubilant Cadista Pharmaceuticals, Inc.

Drug recall: Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, In

FDA enforcement event 87342 · Class III · initiated 19 Feb 2021 · status Terminated · terminated 15 Nov 2022

DrugVoluntary: Firm initiated1 product recordSalisbury, MD

FDA enforcement event 87342 is a drug recall by Jubilant Cadista Pharmaceuticals, Inc. of Salisbury, MD, initiated 19 Feb 2021 and classified Class III, with 1 product record.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 21% of the 299 drug enforcement events initiated in 2021 carry the same class.

Status: Terminated, terminated 15 Nov 2022. Initiation: voluntary: firm initiated. Jubilant Cadista Pharmaceuticals, Inc. has 25 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD.

Reason for recall

"Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card."

Distribution

"USA nationwide, including Puerto Rico."

Product records

Recall numberProductQuantityClassStatusReport date
D-0298-2021Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03635,400 cartonsClass IIITerminated10 Mar 2021

Context

21%of 2021 drug events are Class III299 events that year
1product record in this eventfirm median: 1
25events on this register for the firm

Other enforcement events for Jubilant Cadista Pharmaceuticals, Inc.

InitiatedProduct (first record)TypeClassRecords
27 Dec 2022Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MaryDrugClass III1
18 Jul 2022Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, IndDrugClass II2
1 Apr 2022Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. SDrugClass III1
8 Mar 2022Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, ManufacturedDrugClass I1
20 Aug 2021Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: DrugClass III1
1 Apr 2021Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, IndDrugClass II1
6 Nov 2020clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista PharmaceuticDrugClass II1
26 Oct 2020Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: JubilaDrugClass III1
26 May 2020Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., SDrugClass III1
11 Mar 2020Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics LtdDrugClass II1

All 25 events for Jubilant Cadista Pharmaceuticals, Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "USA nationwide, including Puerto Rico."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 15 Nov 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.