Forest Pharmaceuticals Recalls Bystolic Tablets for Dissolution Failures
Forest Pharmaceuticals is voluntarily recalling one lot of Bystolic (nebivolol hydrochloride) tablets because dissolution test results failed to meet specifications.
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 and is a voluntary precautionary measure for a quality control issue (dissolution failure) with no reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or voluntary recalls.
Plain-English summary
Forest Pharmaceuticals Inc. is voluntarily recalling one lot of Bystolic (nebivolol hydrochloride) 20 mg tablets. The recall affects 21,875 bottles of the 30-tablet prescription medication, identified by Lot A287945 and an expiration date of 08/2015.
The recall was initiated because dissolution test results for the affected lot failed to meet the required specifications throughout the product's shelf life. This means the tablets may not release the active ingredient at the intended rate, potentially affecting the medication's effectiveness.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- BYSTOLIC (NEBIVOLOL HYDROCHLORIDE)
- Brand
- BYSTOLIC
- Manufacturer
- Forest Pharmaceuticals Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 21,875
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: A287945
- Exp: 08/2015
UPCs (4)
- 0304561405909
- 0304561402304
- 0304561420902
- 0304561410903
Distribution
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