Health Canada Posts Two August Recalls of Dr. Reddy’s Semaglutide Injection: a Mislabelled Pen, Then an Impurity Across All Lots
Dr. Reddy’s Laboratories Canada recalled its Semaglutide Injection 1.34 mg/mL twice in August 2026: one lot containing a 4 mg pen labelled as 2 mg (August 12), then every lot of both DINs for an out-of-specification impurity (August 27). Community pharmacies holding the product should quarantine stock and contact patients dispensed the affected lots.
In this article & details
Health Canada’s recalls database lists two Type II recalls by Dr. Reddy’s Laboratories Canada Inc. (Mississauga, Ontario) for its Semaglutide Injection 1.34 mg/mL, both at the retailer level. The first notice (RA-82477, published August 12, 2026) covers a single lot in which “the affected lot contains a 4 mg pen but is labelled as a 2 mg pen.” The second notice (RA-82537, published August 27, 2026) states that “an impurity is out of specification in all lots of the affected products” and covers both DINs. The product is dispensed almost entirely in community pharmacy, so this is a community-pharmacy issue first, although hospital outpatient pharmacies that stock it are affected in the same way.
Affected products
| Recall | Published | DIN | Lots | Issue |
|---|---|---|---|---|
| RA-82477 | August 12, 2026 | 02567806 | 7000544C | 4 mg pen packaged in a carton labelled 2 mg/pen |
| RA-82537 | August 27, 2026 | 02567806 | 7000544, 7000545, 7000546 | Impurity out of specification |
| RA-82537 | August 27, 2026 | 02567814 | 7000542, 7000543, 7000624, 7000628, 7000629 | Impurity out of specification |
Both notices carry the same patient instruction: “Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns.” Health Canada also asks that adverse reactions and product complaints be reported to it.
Practice guidance for pharmacists
- Search inventory by DIN 02567806 and 02567814, quarantine every affected lot, and return it according to the firm’s instructions.
- Pull dispensing records for the affected lots and contact those patients; do not let a patient stop semaglutide abruptly without a plan for continuing therapy.
- Arrange a replacement supply from a non-affected product and counsel on any change in pen device or dose-setting steps.
- At every semaglutide dispense, check that the strength printed on the pen matches the carton and the prescription before it leaves the pharmacy; RA-82477 shows why.
- Report any suspected adverse reaction linked to the recalled lots to Health Canada through MedEffect Canada, and record the recall handling in your pharmacy’s recall log.
Both notices are retailer-level Type II recalls, meaning Health Canada considers the products may cause temporary or medically reversible adverse consequences. Watch the Recalls and Safety Alerts database for any expansion of the impurity recall to additional lots or products.
References
- Semaglutide Injection: Incorrect Pen in Package — Health Canada (Recalls and Safety Alerts), August 12, 2026 · accessed September 10, 2026 (accessed Sep 10, 2026)
- Semaglutide Injection: Out-of-Specification (Impurity) — Health Canada (Recalls and Safety Alerts), August 27, 2026 · accessed September 10, 2026 (accessed Sep 10, 2026)
