Health Canada Recalls Apo-Tiotropium Capsules Over Particle Size Defect

Health Canada has issued a recall for Apo-Tiotropium 18 mcg Capsules manufactured by Apotex Inc. after testing found that certain lots did not meet particle size specifications. The recall covers sixteen affected lot numbers distributed to retailers across Canada, and Health Canada has classified it as a Type II recall.

What Products Are Being Recalled?

The recall applies to Apo-Tiotropium capsules containing Tiotropium bromide monohydrate 18 mcg, sold under Market Authorization DIN 02550865. The affected lot numbers are LC87540, LC87541, LC87616, LC88196, LC88197, LC88316, LC88318, LC88319, LC89638, LC89639, LC89640, LC89641, LC89671, LC89681, LC89725 and LC89783. The product is manufactured and distributed by Apotex Inc., based in Toronto, Ontario.

Why Was This Recall Issued?

According to Health Canada, the particle size in the affected lots did not meet the required specifications. Particle size is a critical quality attribute for inhaled or capsule-based respiratory medications like tiotropium, as it can affect how the drug is released and absorbed in the body, potentially altering the medication’s effectiveness. Health Canada has designated this a Type II recall, indicating a moderate health risk associated with the product quality issue.

Who Is Affected?

The recall affects patients across Canada who have been prescribed Apo-Tiotropium capsules from any of the listed lot numbers. The product was distributed to the retailer level, meaning pharmacies and healthcare providers who dispensed this medication may still have affected stock. Patients currently using this medication for respiratory conditions should check their product packaging against the affected lot list.

What Should You Do?

Consumers and patients are advised to take the following steps:

• Verify whether your Apo-Tiotropium capsules match one of the affected lot numbers.
• Consult your healthcare provider before discontinuing use of the product or if you have any health concerns.
• Contact Apotex Inc. directly if you have questions about the recall.
• Report any side effects related to this health product to Health Canada through its adverse reaction reporting program.
• Report any other safety complaints related to this product to Health Canada.

Official Statement

Health Canada stated that ‘the particle size did not meet the specifications in the affected lots,’ and advised patients to consult their healthcare provider prior to discontinuing use of the affected product, or for any health concerns. The recall was published on July 13, 2026, with an identification number of RA-82325, and the recall depth was noted as reaching the retailer level.