Glenmark recalls Teriflunomide tablets over manufacturing quality deviations
Glenmark Pharmaceuticals is recalling Teriflunomide tablets (14mg) due to manufacturing quality control violations. The recall affects products distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving manufacturing quality control deviations. Class II recalls indicate a potential for adverse health consequences from a defective product. No illnesses or injuries have been reported, making this a risk-of-harm situation where injury has not yet been reported.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA has initiated a recall of Teriflunomide tablets, 14mg, 30-count bottles due to manufacturing quality control deviations (CGMP violations).
The recalled product was distributed nationwide. The affected lot is Lot #17232462 with an expiration date of November 2025, identified by NDC# 68462-424-30.
Patients should consult their healthcare provider or pharmacist to confirm whether their medication is from the affected lot. Individuals currently taking this medication should not discontinue use without medical guidance.
The recalled product
- Product
- TERIFLUNOMIDE (TERIFLUNOMIDE)
- Brand
- TERIFLUNOMIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Tablet
- 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 (2)
- Lot # 17232462
- exp. date Nov-25
UPCs (2)
- 0368462423301
- 0368462424308
Distribution
Distributed nationwide across the United States.
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