Valeant Recalls Vasotec Tablets Due to Incorrect Package Insert Labeling
Valeant Pharmaceuticals is recalling 205,853 bottles of Vasotec (enalapril maleate) tablets because they were packaged with the incorrect version of the package insert.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically low severity because it is unlikely to cause adverse health consequences. The issue is a labeling error involving the package insert.
Plain-English summary
Valeant Pharmaceuticals North America LLC is recalling 205,853 bottles of Vasotec (enalapril maleate) tablets. The recall was initiated because the product was packaged with the incorrect version of the package insert.
The affected product is a prescription-only medication available in 2.5 mg, 5 mg, 10 mg, and 20 mg strengths in 30-count, 90-count, and 1,000-count bottles. The recall covers specific lot numbers and expiration dates listed in the agency's structured data, with distribution reported as nationwide.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- VASOTEC (ENALAPRIL MALEATE)
- Brand
- VASOTEC
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 205,853
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0301870143300
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Valeant Pharmaceuticals North America LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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