CLASS III Drug recall · Reported 20 Dec 2023 · FDA Enforcement Report
Votrient (pazopanib) recalled by Siegfried Barbera, SL
Siegfried Barbera SL is recalling Votrient (pazopanib), distributed nationwide in the US. The recall was initiated on 20 Nov 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0149-2024
- FDA event ID
- 93429
- Recalling firm
- Siegfried Barbera SL, Barbera Del Valles, N/A
- Brand
- Votrient
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Classification
- Class III
- Status
- Completed
- Recall initiated
- 20 Nov 2023
- FDA classified
- 13 Dec 2023
- Reported
- 20 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Potency & Assay
Timeline
| 20 Nov 2023 | Recall initiated by company | |
| 13 Dec 2023 | Classified by FDA | +23 days |
| 20 Dec 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-66
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot# ME2713; Exp. 02/2025 Lot # MF8286, ML1860; Exp. 04/2025
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.