Rizatriptan Benzoate tablets recalled for N-nitroso impurity above acceptable limits
Ascend Laboratories is recalling specific lots of Rizatriptan Benzoate 5 mg tablets nationwide due to detection of N-nitroso-dimethyl-rizatriptan impurity above FDA-recommended limits. Patients should contact their healthcare provider.
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 above regulatory limits. No illnesses or injuries have been reported. The hazard represents a risk of harm from a known health concern (N-nitroso compound detected above acceptable levels), fitting the Score 3 criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ascend Laboratories, LLC is recalling specific lots of Rizatriptan Benzoate Tablets, USP, 5 mg (18 unit-dose tablets per package) distributed nationwide in the United States. The affected lots are: 23142117, 23142119, and 23142122 (expiring May 2026), and lot 24142625 (expiring June 2027).
The recall was initiated due to detection of N-nitroso-dimethyl-rizatriptan impurity at levels above the FDA's recommended acceptable intake limit. This impurity was identified during a current Good Manufacturing Practices (CGMP) compliance review. N-nitroso compounds are of concern due to potential health risks associated with long-term exposure.
Patients using affected lots should contact their healthcare provider or pharmacist before discontinuing the medication. Do not abruptly stop taking rizatriptan without medical guidance, as this may result in rebound headaches or other adverse effects. Healthcare providers should counsel patients on the appropriate course of action, which may include switching to an alternative lot or medication.
The recalled product
- Product
- RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
- Brand
- RIZATRIPTAN BENZOATE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Oral Migraine Medication
- Hazard
- nitrosamine-impurity
- cgmp-violation
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 (6)
- Lot 23142117
- 23142119
- 23142122
- Exp Date: May 2026
- Lot 24142625
- Exp Date: Jun. 2027
UPCs (1)
- 0367877261300
Distribution
Distributed nationwide across the United States.
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