Teriflunomide Tablets 14mg Recalled for CGMP Manufacturing Deviations
Glenmark Pharmaceuticals Inc. is voluntarily recalling Teriflunomide 14mg tablets (Lot #17232462, expiring Nov-25) distributed nationwide due to current good manufacturing practice (CGMP) deviations discovered during production.
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 involves CGMP deviations—a manufacturing/process defect rather than a direct safety hazard. No illnesses or injuries are reported, and no specific contamination or defect affecting drug quality is identified in the source text, making this a voluntary precautionary recall.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Teriflunomide Tablets, 14mg, 30-count bottles with Lot #17232462 and expiration date November 2025. The product is distributed nationwide. The recall was initiated on March 13, 2025, and the FDA classified it as a Class II recall on April 8, 2025.
The recall was issued due to current good manufacturing practice (CGMP) deviations identified in the manufacturing process at Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, which manufactures the product for Glenmark Pharmaceuticals Inc. USA in Mahwah, New Jersey.
Teriflunomide is a prescription medication used to treat multiple sclerosis. Patients who have this medication should contact their healthcare provider or pharmacist for guidance. The source material does not indicate any reported illnesses or injuries related to this lot.
The recalled product
- Product
- TERIFLUNOMIDE (TERIFLUNOMIDE)
- Brand
- TERIFLUNOMIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
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 (2)
- Lot # 17232462
- exp. date Nov-25
UPCs (2)
- 0368462423301
- 0368462424308
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.
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