FDA Recalls Rizatriptan Benzoate Tablets for Manufacturing Impurity
Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate 10mg tablets nationwide due to N-nitroso impurity levels exceeding FDA acceptable limits, affecting 13,296 cartons.
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: This is an FDA Class II recall involving a chemical impurity exceeding acceptable limits. Although no illnesses or injuries have been reported in the source text, the detection of N-nitroso desmethyl rizatriptan impurity at levels above FDA acceptable limits represents a risk-of-harm situation that meets the High severity threshold.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Rizatriptan Benzoate orally disintegrating tablets, USP 10mg. The recall encompasses 13,296 cartons distributed nationwide.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. N-nitroso desmethyl rizatriptan impurity was detected at levels exceeding FDA acceptable limits in the affected tablets. Three lot numbers are affected: 19223402 (expiration 7/2024), 19224858 (expiration 11/2024), and 19232492 (expiration 6/2025).
The affected tablets were distributed to consumers in the United States. Consumers with affected lot numbers should consult with their healthcare provider or pharmacist regarding their medication supply.
The recalled product
- Product
- RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- Affected units
- 13,296
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#: 19223402
- Exp. 7/2024 Lot#: 19224858
- Exp. 11/2024 Lot#: 19232492
- 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
Same brand · RIZATRIPTAN BENZOATE
- HighRizatriptan 10 mg tablets exceed the acceptable intake limit for nitrosamine
FDA (Drugs) · 2025-07-23
- HighRizatriptan 5 mg tablets exceed the acceptable intake limit for nitrosamine
FDA (Drugs) · 2025-07-23
- HighPrescription Rizatriptan Benzoate Tablets Recalled for Chemical Impurity
FDA (Drugs) · 2024-06-12
- HighPrescription migraine drug recalled for manufacturing impurity above FDA limit
FDA (Drugs) · 2024-06-12
- HighRizatriptan Benzoate Tablets Recalled for Excessive N-Nitroso Impurity
FDA (Drugs) · 2024-06-12
Same manufacturer · Glenmark Pharmaceuticals Inc., USA
See all →- ModerateAzelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture
FDA (Drugs) · 2026-08-05
- ModerateAlyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24
- ModerateOndansetron tablets recalled because blister packs are not fully sealed
FDA (Drugs) · 2026-01-07
- CriticalFrozen chopped methi recalled after testing positive for Salmonella
FDA (Drugs) · 2025-12-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
FDA (Drugs) · 2025-12-10
Same hazard · chemical impurity
See all →- SevereErythromycin 500 mg Tablets Recalled for Impurity Above Limits
FDA (Drugs) · 2026-05-27
- HighDuloxetine Delayed-Release Capsules Recalled for Manufacturing Impurity Above Safe Limits
FDA (Drugs) · 2025-01-15
- HighDuloxetine antidepressant recall for chemical impurity above FDA limit
FDA (Drugs) · 2025-01-01
- HighMorphine Sulfate Extended-Release Tablets Recalled for Impurities and Degradation
FDA (Drugs) · 2024-11-13
- HighCinacalcet Tablets Recalled Due to Nitrosamine Impurity
FDA (Drugs) · 2024-11-06