The Recall Desk
ModerateFDA (Drugs)·D-0350-2025·Announced 2025-04-16

Pravastatin Sodium Tablets Recalled Due to Manufacturing Practice Deviations

Glenmark Pharmaceuticals is voluntarily recalling Pravastatin Sodium 80mg tablets due to Current Good Manufacturing Practice deviations. The nationwide recall affects specific lot numbers and remains ongoing.

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 voluntary recall due to CGMP deviations. No illnesses or injuries have been reported in the source material. CGMP deviations represent manufacturing quality and process control concerns rather than identified health hazards, qualifying this as a precautionary voluntary recall typical of Moderate severity.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA, is voluntarily recalling Pravastatin Sodium Tablets, USP, 80mg, in both 90-count and 500-count bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

The affected lots are 17221770, 17221774, 17231251, 17231262, 17232112, and 17232133, with expiration dates ranging from August 2025 through September 2026. The product was distributed nationwide throughout the United States.

Consumers taking Pravastatin Sodium from the affected lots should contact their healthcare provider or pharmacist to determine if their medication is part of this recall. Do not discontinue the medication without professional guidance.

This is a firm-initiated voluntary recall that remains ongoing. For more information, consumers should contact their pharmacist or the FDA.

The recalled product

Product
PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Brand
PRAVASTATIN SODIUM
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Statin
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 (7)

  • Lot # 17221770
  • exp. date Aug-25 17221774
  • exp. date Aug-25 17231251
  • exp. date May-26 17231262
  • exp. date May-26 17232112
  • exp. date Sep-26 17232133
  • exp. date Sep-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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