Aurobindo Pharma USA Inc recalls Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279
Aurobindo Pharma recalls 2.5mg Nebivolol tablets with nitrosamine impurity above safety limits. Rx-only bottles from specific lots may pose health risks.
Recall notice
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Contact the company & request your remedy
What happened, in plain English
Aurobindo Pharma is recalling 2.5mg Nebivolol tablets that contain a nitrosamine impurity above safe levels. This could pose health risks to people taking the medication. Read more at govinfonow.com/recall/32384-aurobindo-nebivolol-tablets-recall-nitrosamine-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32384-aurobindo-nebivolol-tablets-recall-nitrosamine-impurity-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0149-2025
Cite this page
“Aurobindo Nebivolol Tablets Recall: Nitrosamine Impurity Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32384-aurobindo-nebivolol-tablets-recall-nitrosamine-impurity-risk. Based on FDA recall #D-0149-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0149-2025%22&limit=1).
Why it’s dangerous
The tablets contain a nitrosamine impurity (N-Nitroso Nebivolol) that exceeds the acceptable intake limit. This impurity could potentially cause health issues when taken regularly.
Who’s affected
People with prescriptions for this medication are affected. Those taking the recalled tablets may be at risk due to the impurity.
How to tell if you have this one
Check for 2.5mg Nebivolol tablets in 30-count bottles with NDC 59651-137-30. Look for lot numbers NB0224001A or NB0224001B with expiration date 04/2027.
- Brand
Aurobindo Pharma- Category
Drug
What to do — step by step
Check Your Medication
Verify the product details: 2.5mg Nebivolol tablets, 30-count bottles, NDC 59651-137-30, lot numbers NB0224001A or NB0224001B.
Questions people ask
Is this medication safe to take?
The recall states the tablets contain a nitrosamine impurity above acceptable limits, so they are not safe to take.
What should I do if I have this medication?
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance.
How can I tell if I have the recalled product?
Check for 2.5mg Nebivolol tablets in 30-count bottles with NDC 59651-137-30 and lot numbers NB0224001A or NB0224001B.
Contact Aurobindo Pharma
We’ve drafted a message you can send Aurobindo Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0149-2025 — Aurobindo Pharma Aurobindo Pharma Hello, I own a Aurobindo Pharma that is covered by recall D-0149-2025 from Aurobindo Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0149-2025 (December 6, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0149-2025 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.