Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited,...

FDA Recall #D-0222-2026 — Class III — November 18, 2025

Recall #D-0222-2026 Date: November 18, 2025 Classification: Class III Status: Ongoing

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.

Reason for Recall

Cross Contamination with Other Products

Recalling Firm

Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

672 90-count bottles

Distribution

U.S. Nationwide

Code Information

Lot# 17240988; Exp. 05/31/2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated