Prescription drug recall: Aurobindo Nebivolol tablets contain excess nitrosamine impurity
Aurobindo Pharma USA is recalling Nebivolol 2.5 mg tablets nationwide due to manufacturing deviations that resulted in the presence of N-Nitroso Nebivolol, a nitrosamine impurity, above acceptable intake limits.
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 for manufacturing deviation resulting in nitrosamine impurity above acceptable intake limits. No reported illnesses or injuries, so this qualifies as a risk-of-harm product without reported injury per the severity rubric.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Nebivolol 2.5 mg tablets, 30-count bottles distributed nationwide in the United States. The specific product is NDC 59651-137-30, and the recall affects lot numbers NB0224001A and NB0224001B with an expiration date of 04/2027. This is a prescription-only medication.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations discovered during manufacturing. The recalled tablets contain N-Nitroso Nebivolol, a nitrosamine-related impurity, at levels above the acceptable intake limit established by the FDA.
The recalled product
- Product
- NEBIVOLOL (NEBIVOLOL)
- Brand
- NEBIVOLOL
- Manufacturer
- Aurobindo Pharma USA Inc
- Category
- Drug
- Hazard
- nitrosamine-impurity
- 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 #: NB0224001A and NB0224001B
- Exp. Date 04/2027
UPCs (1)
- 0359651137307
Distribution
Distributed nationwide across the United States.
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