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.
What this means for you
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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