CLASS III Drug recall · Reported 10 Mar 2021 · FDA Enforcement Report

Methylprednisolone Tablets USP, 4 MG recalled by Jubilant Cadista

Jubilant Cadista Pharmaceuticals is recalling Methylprednisolone Tablets USP, 4 MG, distributed nationwide in the US. The recall was initiated on 19 Feb 2021 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: 20K0043P, 20K0044P, 20K0042P, Exp 08/2022; 20L0026P, 20L0027P, 20L0028P, 20L0029P, 20L0030P, Exp 09/2022

Quantity recalled635,400 cartons

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0298-2021
FDA event ID: 87342
Recalling firm: Jubilant Cadista Pharmaceuticals, Salisbury, MD
Classification: Class III
Status: Terminated
Recall initiated: 19 Feb 2021
FDA classified: 4 Mar 2021
Reported: 10 Mar 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects

Timeline

19 Feb 2021	Recall initiated by company
4 Mar 2021	Classified by FDA	+13 days
10 Mar 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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 was distributed

USA nationwide, including Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot #: 20K0043P, 20K0044P, 20K0042P, Exp 08/2022; 20L0026P, 20L0027P, 20L0028P, 20L0029P, 20L0030P, Exp 09/2022

Where was it sold?

USA nationwide, including Puerto Rico.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Jubilant Cadista Pharmaceuticals

All 31

Reported	Class	Recall	Company	Reason	Where
11 Jan 2023Drug	CLASS III	Prochlorperazine Maleate Tablets, USP 5mg recalled by Jubilant CadistaProchlorperazine Maleate	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS II	Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS II	Irbesartan Tablets, USP, 75 mg recalled by Jubilant CadistaIrbesartan	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
13 Apr 2022Drug	CLASS III	Methylprednisolone Tablets, USP 4mg recalled by Jubilant Cadista	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
6 Apr 2022Drug	CLASS I	Meclizine Hydrochloride Tablets USP, 12.5 mg recalledMeclizine Hydrochloride	Jubilant Cadista Pharmaceuticals	Labeling Errors	5 states

Other Methylprednisolone recalls

All 69

Reported	Class	Recall	Company	Reason	Where
4 Feb 2026Drug	CLASS II	methylprednisolone tablets, USP Dosepak, 4 mg recalled by GreenstoneMethylprednisolone	Greenstone	Other	Nationwide
22 May 2024Drug	CLASS II	MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate	Sagent Pharmaceuticals	Particulate Matter	Nationwide
13 Mar 2024Drug	CLASS II	Methylprednisolone acetate Injectable Suspension recalled by Eugia USMethylprednisolone Acetate	Eugia US	Potency & Assay	4 states
31 May 2023Drug	CLASS III	Methylprednisolone Acetate Injectable Suspension recalled	Amneal Pharmaceuticals of New York	Packaging Defects	Nationwide
22 Feb 2023Drug	CLASS II	Methylprednisolone 12MG IN NS Syringe, steroid recalled	Sentara Infusion Services	Sterility	Nationwide