SUVEXX Assay Out of Specification Recall - Lot 0000159323
Summary
Health Canada has issued a Type III recall for SUVEXX tablets (DIN 02496305, containing Sumatriptan 85mg and Naproxen sodium 500mg), lot 0000159323, distributed nationally in Canada. The recall was initiated after the assay was found to be out of specification in the affected lot. Aralez Pharmaceuticals Canada Inc. issued the recall with a depth covering retailers. Patients and healthcare providers are advised to verify if their product is affected and to consult a healthcare provider before discontinuing use.
What changed
Health Canada issued a Type III health product recall for SUVEXX tablets (Sumatriptan 85mg/Naproxen sodium 500mg), lot 0000159323, manufactured by Aralez Pharmaceuticals Canada Inc. The recall was triggered by an out-of-specification assay result detected during quality testing. The product was distributed nationally through retail channels.
Pharmaceutical distributors, retailers, and healthcare providers in possession of this lot should immediately verify their inventory and quarantine any affected stock. Patients who have received SUVEXX from this lot should consult their healthcare provider before making any changes to their medication regimen. The Type III classification indicates a situation where use of, or exposure to, the affected product is not likely to cause adverse health consequences, but the recall is being conducted as a precautionary measure.
What to do next
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
SUVEXX: The assay is out of specification in the affected lot.
Brand(s)
Last updated
2026-04-20
Summary
Product SUVEXX Issue Health products - Product quality What to do Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
Distribution National
Affected products
| Product Name | Market Authorization | Dosage Form | Strength | Lot number |
|---|---|---|---|---|
| SUVEXX | DIN 02496305 | Tablet | Sumatriptan 85mg | |
| Naproxen sodium 500mg | 0000159323 |
Issue
The assay is out of specification in the affected lot.
What you should do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Additional information
Background
Depth of recall: Retailers
Details
Original published date:
2026-04-20
Alert / recall type Health product recall Category Health products - Drugs Companies ARALEZ PHARMACEUTICALS CANADA INC
6733 Mississauga Rd, Suite 800
Mississauga, ON
L5N 6J5
Published by Health Canada Audience General public Healthcare Industry Distribution National Recall class Type III Recall date
2026-04-15
Identification number RA-81912
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