Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited,...
FDA Drug Recall #D-0222-2026 - Class III, November 18, 2025
Recall Summary
| Recall Number | D-0222-2026 |
| Classification | Class III, Low risk |
| Date Initiated | November 18, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Glenmark Pharmaceuticals Inc., USA |
| Location | Mahwah, NJ |
| Product Type | Drugs |
| Quantity | 672 90-count bottles |
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
Distribution Pattern
U.S. Nationwide
Lot / Code Information
Lot# 17240988; Exp. 05/31/2026
Other Recalls from Glenmark Pharmaceuticals Inc., USA
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0731-2026 | Class II | Azelaic Acid Gel, 15%, 50 gram tubes, For Topic... | Jul 23, 2026 |
| D-0588-2026 | Class II | Alyacen 7/7/7, Norethindrone and Ethinyl Estrad... | May 27, 2026 |
| D-0246-2026 | Class II | Ondansetron Orally Disintegrating Tablets, USP,... | Dec 30, 2025 |
| D-0199-2026 | Class III | Bisoprolol Fumarate and Hydrochlorothiazide Tab... | Nov 21, 2025 |
| D-0662-2025 | Class II | Azelaic Acid Gel, 15%, 50 grams, For Topical Us... | Sep 17, 2025 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections, all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications, even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications, use a drug take-back program.