Medications & Supplements/Prescription Drugs

Jubilant Cadista Methylprednisolone Tablets Recalled for Subpotency

Agency Publication Date: April 6, 2022

Summary

Jubilant Cadista Pharmaceuticals, Inc. has recalled 19,222 bottles (100-count) of Methylprednisolone Tablets, USP 4mg, which is a prescription medication used to treat various inflammatory conditions. The recall was issued because the tablets were found to be subpotent, meaning they may not contain the full concentration of the active ingredient as required. To date, no incidents or injuries related to this issue have been reported.

Risk

Because the tablets are subpotent, patients taking this medication may receive a lower dose than their doctor intended. This can result in the ineffective treatment of the underlying medical condition being managed by the steroid.

What You Should Do

The recalled product is Methylprednisolone Tablets, USP 4mg, sold in 100-count bottles with NDC 59746-001-06 and lot number 21 P0322 (Expiration Date: 01/2023).
Check your prescription bottle label for the Jubilant Cadista Pharmaceuticals brand name, NDC 59746-001-06, and lot number 21 P0322 to determine if your medication is affected.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Methylprednisolone Tablets, USP 4mg (100-count bottle)

Variants: 4mg, Tablet

Lot Numbers:

21 P0322 (Exp. 01/2023)

NDC:

59746-001-06

Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89923

Status: Resolved

Manufacturer: Jubilant Cadista Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 19,222 Bottles (100-count)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled product is Methylprednisolone Tablets, USP 4mg, sold in 100-count bottles with NDC 59746-001-06 and lot number 21 P0322 (Expiration Date: 01/2023).

Check your prescription bottle label for the Jubilant Cadista Pharmaceuticals brand name, NDC 59746-001-06, and lot number 21 P0322 to determine if your medication is affected.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.