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Drug FDA Class III Ongoing Chemical

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.

Glenmark Pharmaceuticals Inc., USA Published Dec 17, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Glenmark Pharmaceuticals Inc., USA or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Cross Contamination with Other Products

Hazards

Cross-contamination with other products · primary

Affected products (1)

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.

NEBIVOLOL · 672 90-count bottles

NDC: 42291-871, 42291-872, 42291-873, 42291-874, 42291-871-30, 42291-872-90, 42291-873-90, 42291-874-90
Lot codes: 17240988
Code info: Lot# 17240988; Exp. 05/31/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 18, 2025
  2. Published
    Dec 17, 2025
Recall number
D-0222-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.