The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0349-2025·Announced 2025-04-16

Pravastatin Sodium 20mg Tablets Recalled for CGMP Deviations

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Pravastatin Sodium Tablets, USP, 20mg, 90-count bottles (Lot # 17230810, expiration Mar-26) nationwide due to manufacturing process deviations.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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: FDA Class II classification applies. The source describes CGMP deviations but reports no illnesses or injuries, making this a precautionary manufacturing-compliance recall rather than a safety incident.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Pravastatin Sodium Tablets, USP, 20mg, in 90-count bottles distributed nationwide. The recall affects product manufactured for Northstar Rx LLC, Memphis, TN, with NDC# 16714-559-01. The affected lot is Lot # 17230810 with an expiration date of March 2026.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. This is a Class II recall, meaning the product is unlikely to cause adverse health consequences but warrants action to prevent potential harm.

Patients taking this medication should contact their pharmacy or healthcare provider. The recall was initiated on March 13, 2025, and classified by the FDA on April 8, 2025. For more information, consult the FDA's drug recall database or contact Glenmark Pharmaceuticals Inc., USA.

The recalled product

Product
PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Brand
PRAVASTATIN SODIUM
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription
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 # 17230810
  • exp. date Mar-26

UPCs (3)

  • 0316714570013
  • 0316714559018
  • 0316714560014

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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