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.
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 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
- manufacturing-defect
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.
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- HighPrescription Drug Indomethacin Recalled Due to Label Mix-Up
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