The Recall Desk
ModerateFDA (Drugs)·D-0149-2024·Announced 2023-12-20

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.

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: 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.

Related recalls

Same hazard · failed dissolution

See all →