The Recall Desk
ModerateFDA (Drugs)·D-0325-2025·Announced 2025-04-16

Glenmark Pharmaceuticals Recalls Pravastatin Sodium Tablets 80mg

Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Pravastatin Sodium Tablets 80mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall applies to affected lots distributed nationwide and was initiated voluntarily by the firm.

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: The recall is FDA Class II and voluntary with no reported illness or injury. The hazard involves CGMP deviations, which represent a potential quality concern but without specific evidence of harm, placing this in the Moderate category.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling certain lots of Pravastatin Sodium Tablets 80mg (90-count bottles, NDC 68462-198-90) manufactured in India and distributed U.S. nationwide. The affected lots are: 17221771 (exp. Aug-25), 17230930 (exp. Apr-26), 17230931 (exp. Apr-26), 17231252 (exp. May-26), 17231274 (exp. May-26), 17231855 (exp. Aug-26), 17231916 (exp. Aug-26), 17231917 (exp. Aug-26), and 17231945 (exp. Aug-26).

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and was initiated by the firm on March 13, 2025. The FDA classified this recall as Class II on April 8, 2025.

Consumers who have bottles of Pravastatin Sodium Tablets 80mg from the affected lots should contact their pharmacist or healthcare provider for guidance. Patients should not stop taking their medication without consulting their healthcare provider.

The recalled product

Product
PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Brand
PRAVASTATIN SODIUM
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription Statin
Hazard
  • cgmp-deviations
  • manufacturing-control

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 (10)

  • Lot # 17221771
  • exp. date Aug-25 17230930
  • exp. date Apr-26 17230931
  • exp. date Apr-26 17231252
  • exp. date May-26 17231274
  • exp. date May-26 17231855
  • exp. date Aug-26 17231916
  • exp. date Aug-26 17231917
  • exp. date Aug-26 17231945
  • exp. date Aug-26

UPCs (2)

  • 0368462195901
  • 0368462198902

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · PRAVASTATIN SODIUM

Same category