Forest Pharmaceuticals Recalls Bystolic Tablets for Dissolution Failure
Forest Pharmaceuticals is recalling Bystolic (nebivolol) 20 mg tablets because they failed a dissolution specification at a 6-month stability time point.
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, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The specific defect is a failure in dissolution specification, which is a quality control issue rather than a direct contamination or acute hazard like a high-risk pathogen or structural defect.
Plain-English summary
Forest Pharmaceuticals, Inc. is recalling Bystolic (nebivolol) tablets, 20 mg, packaged as 7 tablets per bottle. The recall involves 94,584 cartons of the product, specifically Lot A369286 with an expiration date of January 31, 2016. The product is identified by NDC 0456-1420-07.
The recall was initiated because the tablets failed a dissolution specification at the 6-month stability time point. Dissolution testing ensures that the medication releases its active ingredient at the proper rate for absorption in the body. A failure in this specification may mean the medication does not perform as intended.
The affected product was distributed nationwide, including Puerto Rico. It was available as a professional sample and is prescription-only. Patients and healthcare providers should stop using the affected lot and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07
- Manufacturer
- Forest Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 94,584
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 A369286
- exp. date 31 Jan 2016
Distribution
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