The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0752-2022·Announced 2022-04-13

FDA Voluntary Recall of Methylprednisolone Tablets for Subpotency

Jubilant Cadista Pharmaceuticals is recalling Methylprednisolone Tablets USP 4mg because they contain less active ingredient than labeled. Lot 21 P0322 was distributed nationwide and in Puerto Rico.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III voluntary recall with no reported illnesses or injuries. Per the rubric, Class III recalls are typically scored as 1 or 2; voluntary precautionary recalls are classified as Moderate (2). Subpotency is a manufacturing defect affecting drug efficacy, but poses no immediate physical danger.

Plain-English summary

Jubilant Cadista Pharmaceuticals, Inc. has recalled one lot of Methylprednisolone Tablets, USP 4mg in 100-count bottles due to subpotency. The tablets were found to contain less active ingredient than the labeled amount of 4mg per tablet.

Lot 21 P0322 with expiration date 01/2023 was distributed nationwide in the United States and Puerto Rico. Approximately 19,222 bottles (100-count) were affected. The manufacturer initiated the recall on April 1, 2022, and the FDA terminated the recall on April 3, 2023.

Patients taking this medication who have concerns should consult their healthcare provider. Individuals with the recalled product should contact the manufacturer or speak with their pharmacist about returning or replacing the affected bottles.

This was a Class III voluntary recall, which is the lowest FDA priority category for drug recalls.

The recalled product

Product
Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06
Manufacturer
Jubilant Cadista Pharmaceuticals, Inc.
Category
Drug
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 21 P0322
  • Exp. 01/2023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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