Nebivolol Tablets recall
FDA recall D-0149-2025 · initiated Dec 6, 2024
Aurobindo Pharma USA Inc recalled Nebivolol Tablets in Dec 2024 — an FDA Class II recall (D-0149-2025) because CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- Product
- Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30
- Recalling company
- Aurobindo Pharma Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Dec 6, 2024
- FDA report date
- Dec 25, 2024
Frequently asked
- Was Nebivolol Tablets recalled?
- Aurobindo Pharma USA Inc recalled Nebivolol Tablets in Dec 2024 — an FDA Class II recall (D-0149-2025) because CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Nebivolol Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0149-2025 was: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
- Is a recalled Nebivolol Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Nebivolol Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0149-2025.