The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0329-2025·Announced 2025-04-16

Glenmark Pharmaceuticals Recalls Indomethacin Capsules for Manufacturing Deviations

Glenmark Pharmaceuticals is voluntarily recalling Indomethacin Extended-Release Capsules (75mg) distributed nationwide due to Good Manufacturing Practice deviations identified during FDA oversight.

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: This is a Class II voluntary precautionary recall with no reported illnesses or injuries. Per the severity rubric, voluntary precautionary recalls are classified as Moderate (score 2).

Plain-English summary

Glenmark Pharmaceuticals Inc., USA initiated a voluntary recall of Indomethacin Extended-Release Capsules (75mg) in March 2025. The FDA classified the recall as Class II.

The recall was initiated due to deviations from Current Good Manufacturing Practice (CGMP) standards identified during manufacturing. Glenmark Pharmaceuticals discovered these deviations and notified the FDA.

Affected products are distributed nationwide and include Lot #17232323 and Lot #17232335, both expiring in October 2025. The product NDC number is 68462-325-60. Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain and inflammation.

Consumers currently taking this medication should consult their pharmacist or healthcare provider if they have concerns. Patients should verify their medication against the recalled lot numbers and expiration dates.

The recalled product

Product
INDOMETHACIN (INDOMETHACIN)
Brand
INDOMETHACIN
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 (4)

  • Lot # 17232323
  • exp. date Oct-25 17232335
  • exp. date Oct-25 17232323
  • exp. date Oct-25

UPCs (1)

  • 0368462325605

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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