The Recall Desk
ModerateFDA (Drugs)·D-0341-2025·Announced 2025-04-16

Pravastatin Sodium Tablets Recalled Due to Manufacturing Deviations

Glenmark Pharmaceuticals Inc. is recalling Pravastatin Sodium 20mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects specific lot numbers distributed across the U.S.

What this means for you

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 II recall for CGMP deviations. No illnesses, injuries, or actual harm from the manufacturing deviation is reported in the source text. CGMP violations represent potential compliance and process issues rather than confirmed product defects or contamination.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Pravastatin Sodium Tablets 20mg in 500-count bottles (NDC# 68462-196-05) and 90-count bottles (NDC# 68462-196-90) distributed nationwide. The recall was initiated on March 13, 2025.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. The affected lot numbers are 17230810, 17230811, 17232501, and 17232502, with expiration dates of March 2026 and November 2026.

This is a voluntary, firm-initiated recall that was notified to the FDA by letter. Patients taking affected tablets should consult their healthcare provider or pharmacist about alternative supplies. Consumers who have purchased affected lots should stop taking the product and contact their pharmacy or Glenmark for guidance on obtaining replacement medication.

The recalled product

Product
PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Brand
PRAVASTATIN SODIUM
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription Tablet
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 (6)

  • Lot # 17230810
  • exp. date Mar-26 17230811
  • exp. date Mar-26 17230810
  • exp. date Mar-26 17232501
  • exp. date Nov-26 17232502
  • exp. date Nov-26

UPCs (2)

  • 0368462195901
  • 0368462198902

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 39 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 39 products in this recall →

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