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.
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: 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
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.
Related recalls
Same brand · NEBIVOLOL
- CriticalFrozen chopped methi recalled after testing positive for Salmonella
FDA (Drugs) · 2025-12-17
Same manufacturer · Aurobindo Pharma USA Inc
See all →- ModerateDicyclomine Hydrochloride Capsules Recalled for Empty Capsules
FDA (Drugs) · 2026-08-12
- ModerateAmazon Basic Care Acetaminophen 325 mg Tablets Recalled Due to Discoloration
FDA (Drugs) · 2025-06-25
- HighPrescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2024-12-11
- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit
FDA (Drugs) · 2024-12-11
- HighFDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity
FDA (Drugs) · 2024-12-11
Same hazard · nitrosamine impurity
See all →- HighEnovachem duloxetine capsules exceed the nitrosamine acceptable intake limit
FDA (Drugs) · 2026-06-10
- HighCipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighCipla cinacalcet 30 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighCipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighPrazosin hydrochloride 100-count bottles recalled over nitrosamine impurity
FDA (Drugs) · 2026-04-08
Similar recalls
- LowCarvedilol Tablets Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2021-12-01
- SevereCarvedilol Tablets Recalled Due to N-Nitroso Impurity
FDA (Drugs) · 2025-06-04
- HighPrescription Carvedilol recalled for manufacturing impurity exceeding FDA specifications
FDA (Drugs) · 2025-02-12
- HighCarvedilol Tablets Recalled for Carcinogenic N-Nitroso Impurity Manufacturing Defect
FDA (Drugs) · 2025-02-12
- SevereCarvedilol Tablets 25 mg Recalled Due to Impurity Above Acceptable Limit
FDA (Drugs) · 2025-06-04
- SevereAurobindo Ranitidine Capsules Recalled for NDMA Contamination
FDA (Drugs) · 2019-12-04