CLASS III Drug recall · Reported 13 Apr 2022 · FDA Enforcement Report

Methylprednisolone Tablets, USP 4mg recalled by Jubilant Cadista

Jubilant Cadista Pharmaceuticals is recalling Methylprednisolone Tablets, USP 4mg, distributed nationwide in the US. The recall was initiated on 1 Apr 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot # 21 P0322, Exp. 01/2023

Quantity recalled19,222 Bottles (100-count)

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-0752-2022
FDA event ID: 89923
Recalling firm: Jubilant Cadista Pharmaceuticals, Salisbury, MD
Classification: Class III
Status: Terminated
Recall initiated: 1 Apr 2022
FDA classified: 6 Apr 2022
Reported: 13 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

1 Apr 2022	Recall initiated by company
6 Apr 2022	Classified by FDA	+5 days
13 Apr 2022	Published in enforcement report	+7 days

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

Reason for recall

Subpotent

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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 was distributed

Nationwide in the USA and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Subpotent

Which lots are affected?

Lot # 21 P0322, Exp. 01/2023

Where was it sold?

Nationwide in the USA and 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
6 Apr 2022Drug	CLASS I	Meclizine Hydrochloride Tablets USP, 12.5 mg recalledMeclizine Hydrochloride	Jubilant Cadista Pharmaceuticals	Labeling Errors	5 states
8 Sep 2021Drug	CLASS III	Donepezil HCL Tablets, USP, 5 mg recalled by Jubilant Cadista	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide

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