Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest...
FDA Drug Recall #D-1412-2014 — Class II — June 19, 2014
Recall Summary
| Recall Number | D-1412-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 19, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Forest Pharmaceuticals Inc |
| Location | Earth City, MO |
| Product Type | Drugs |
| Quantity | 92,544 Bottles |
Product Description
Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.
Reason for Recall
Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Distribution Pattern
Nationwide including Puerto Rico.
Lot / Code Information
Lot # A308879, Expiry: 09/2015
Other Recalls from Forest Pharmaceuticals Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0036-2015 | Class II | Bystolic (nebivolol) tablets, 20 mg/tablet, pac... | Sep 26, 2014 |
| D-1348-2014 | Class II | Bystolic (nebivolol), 20 mg/tablet, 30 tablets ... | May 12, 2014 |
| D-1063-2014 | Class III | Namenda XR (memantine HCl), 7 mg extended relea... | Nov 13, 2013 |
| D-1065-2014 | Class III | Namenda XR (memantine HCl), sample pack, 28 mg,... | Nov 13, 2013 |
| D-1064-2014 | Class III | Namenda XR (memantine HCl), titration pack (7 m... | Nov 13, 2013 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
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.