Prescription migraine drug recalled for manufacturing impurity above FDA limit
Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate tablets for exceeding FDA acceptable limits of N-Nitroso Desmethyl Rizatriptan impurity. The recall affects 2,400 cartons distributed nationwide.
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 3/5 (High).
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: This is an FDA Class II recall for a manufacturing defect involving an impurity exceeding acceptable limits in a prescription medication. No illnesses or injuries have been reported in the source text, so the hazard remains theoretical. Per the rubric, theoretical hazards with no reported injury score at most 3.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Rizatriptan Benzoate Orally Disintegrating Tablets, 5mg (NDC 68462-467 and 68462-468), manufactured in India. The recall is due to manufacturing deviations where testing detected N-Nitroso Desmethyl Rizatriptan impurity at levels exceeding FDA acceptable limits.
The affected product was distributed nationwide in the United States. Two lot numbers are involved: Lot #19224857 (expiration 11/2024) and Lot #19232493 (expiration 6/2025). A total of 2,400 cartons were distributed.
Patients taking Rizatriptan Benzoate from the affected lots should contact their healthcare provider or pharmacy. Do not discontinue use of the medication without consulting a healthcare professional, as this could affect migraine treatment. Return the medication to a pharmacy or dispose of it according to local guidelines.
The recalled product
- Product
- RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Affected units
- 2,400
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 (3)
- Lot#: 19224857
- Exp. 11/2024 Lot#: 19232493
- Exp. 6/2025
UPCs (2)
- 0368462467060
- 0368462468067
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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