Sandoz Fesoterodine Fumarate recall in Canada: impurity out of specification
In plain language
This recall involves Sandoz Fesoterodine Fumarate 8 mg tablets sold in Canada. It's being recalled because an impurity is out of specification in affected lots. Consult your healthcare provider before stopping use and follow the return steps in the official notice.
What to do
- Consult your healthcare provider before stopping use of the product.
- Contact Sandoz Canada if you have questions.
- Report any health product related side effects to Health Canada.
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Affected products
SANDOZ FESOTERODINE FUMARATE 8 mg Tablet (Extended-Release)
Model: DIN 02521776
Lot: 2305011682
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 2305011682
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: DIN 02521776
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
This recall involves Sandoz Fesoterodine Fumarate 8 mg tablets sold in Canada. It's being recalled because an impurity is out of specification in affected lots. Consult your healthcare provider before stopping use and follow the return steps in the official notice.
What should consumers do?
Consult your healthcare provider before stopping use of the product. Contact Sandoz Canada if you have questions. Report any health product related side effects to Health Canada.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on December 9, 2024.
Is the Sandoz Fesoterodine Fumarate brand affected by this recall?
Yes, Sandoz Fesoterodine Fumarate products are affected by this recall. This recall involves Sandoz Fesoterodine Fumarate 8 mg tablets sold in Canada. It's being recalled because an impurity is out of specification in affected lots. Consult your healthcare provider before stopping use and follow the return steps in the official notice.