The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0339-2025·Announced 2025-04-16

Rosuvastatin Calcium Tablets Recalled Nationwide Due to Manufacturing Deviations

Glenmark Pharmaceuticals is voluntarily recalling Rosuvastatin Calcium 40mg tablets nationwide due to manufacturing practice deviations. The recall affects specific lot numbers expiring February through June 2026.

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 recall with no reported illnesses or injuries and a voluntary, firm-initiated precautionary recall based on identified CGMP deviations. The specific nature of the manufacturing deviation is not disclosed in the source material.

Plain-English summary

Glenmark Pharmaceuticals Inc. is voluntarily recalling Rosuvastatin Calcium 40mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified in their manufacturing process. The recall involves specific lot numbers with expiration dates from February through June 2026, supplied in 30-count bottles (NDC# 68462-264-30). The product was manufactured by Glenmark Pharmaceuticals Limited in Pithampur, India, for Glenmark Pharmaceuticals Inc. in Mahwah, New Jersey.

The recall was initiated by the firm on March 13, 2025, and classified as FDA Class II on April 8, 2025. No illnesses or injuries have been reported in connection with this recall.

The affected product was distributed nationwide throughout the United States. Consumers and healthcare providers who have dispensed or received this medication should consult with their pharmacy or healthcare provider regarding their rosuvastatin therapy.

The recalled product

Product
ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
Brand
ROSUVASTATIN CALCIUM
Manufacturer
Glenmark Pharmaceuticals Inc., USA
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 (12)

  • Lot # 17240389
  • exp. date Feb-26 17240390
  • exp. date Feb-26 17240426
  • exp. date Feb-26 17240427
  • exp. date Feb-26 17240428
  • exp. date Feb-26 17240778
  • exp. date Apr-26 17241055
  • exp. date May-26 17241074
  • exp. date Jun-26 17241075
  • exp. date Jun-26 17241091
  • exp. date Jun-26 17241100
  • exp. date Jun-26

UPCs (4)

  • 0368462263907
  • 0368462261903
  • 0368462262900
  • 0368462264300

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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