Nebivolol Tablet
FDA Recall NDC 42291-871
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nebivolol (NDC 42291-871). A significant event, classified as Class III, was initiated on Nov 18, 2025 by Avkare. The reported reason for this action was: "Cross Contamination with Other Products"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Cross Contamination with Other Products
Nov 18, 2025
Dec 17, 2025
672 90-count bottles
Recall Profile & Regulatory Data
Event ID
98014
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.
Batch or Lot Expiration Information
Lot# 17240988; Exp. 05/31/2026
Affected Packages Involved in this Recall
42291-871-30Product
42291-872-90Product
42291-873-90Product
42291-874-90Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
