Forest Pharmaceuticals Recalls Bystolic Tablets for Dissolution Failure
Forest Pharmaceuticals is recalling Bystolic (nebivolol) 20 mg tablets because they failed stage III dissolution testing. The recall affects 92,544 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a failure in dissolution specifications, which is a quality control issue that may affect drug efficacy but does not involve acute toxicity or reported injuries, fitting the 'Moderate' criteria for low-risk contamination or quality defects.
Plain-English summary
Forest Pharmaceuticals, Inc. is recalling Bystolic (nebivolol) tablets, 20 mg/tablet, in 7-tablet professional sample bottles. The recall involves 92,544 bottles of the prescription medication, identified by Lot # A308879 with an expiration date of 09/2015. The product was distributed nationwide, including Puerto Rico.
The recall was initiated because the drug failed stage III dissolution testing. Dissolution testing ensures that the medication breaks down properly in the body to release the active ingredient as intended. A failure in this specification means the medication may not perform as expected.
Consumers and healthcare providers should stop using the affected Bystolic tablets and return them to their pharmacy or contact Forest Pharmaceuticals for a refund or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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.
- Manufacturer
- Forest Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 92,544
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # A308879
- Expiry: 09/2015
Distribution
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