Prescription cancer medication recalled for failed dissolution specifications
Votrient (pazopanib hydrochloride) 200 mg tablets are being recalled nationwide. Three lot numbers failed to meet dissolution specifications.
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 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: This is an FDA Class III drug recall for a manufacturing quality defect. Class III recalls represent the lowest risk classification from the FDA. No illnesses or injuries have been reported in connection with this recall.
Plain-English summary
Novartis Pharmaceuticals is recalling Votrient (pazopanib hydrochloride) 200 mg tablets distributed nationwide. Three lot numbers are affected: ME2713 (expires 02/2025), MF8286 (expires 04/2025), and ML1860 (expires 04/2025). The tablets are manufactured by Siegfried Barbera, SL in Barbera del Valles, Spain.
The tablets failed to meet established dissolution specifications.
Patients who have received these tablets should check the lot number on their bottle label. Those with affected lot numbers should contact their healthcare provider or pharmacist to discuss next steps. Do not discontinue use without medical guidance.
The recalled product
- Product
- VOTRIENT (PAZOPANIB HYDROCHLORIDE)
- Brand
- VOTRIENT
- Manufacturer
- Siegfried Barbera, SL
- Category
- Drug
- Hazard
- Affected units
- 2,016
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 (4)
- Lot# ME2713
- Exp. 02/2025 Lot # MF8286
- ML1860
- Exp. 04/2025
Distribution
Distributed nationwide across the United States.
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