Health Canada Flags Pendopharm PDP-Diphenhydramine Capsule Recall 2026

Health Canada has classified a recall of Pendopharm’s PDP-Diphenhydramine 25 mg capsules as Type II after an impurity was found to be out of specification in six lots. The recall was published on October 5, 2026, under identification number RA-82720, and applies to products distributed across Canada.

The impurity, identified as N-Nitroso-N-Desmethyl Diphenhydramine, exceeded its allowed specification in the affected lots. Health Canada lists the issue as a product quality concern. The recall depth is at the retail level.

Products Affected by This Recall

The recall covers a single product in capsule form. The details below come directly from the Health Canada notice.

• Brand: Pendopharm
• Product: PDP-DIPHENHYDRAMINE
• Dosage form and strength: Capsule, 25 MG
• Market authorization: DIN 00757683
• Lot numbers: 642913, 643904, 648034, 651074, 653544, 656693

Only capsules from these six lots are part of the recall. Check the lot number printed on your package against the list above to confirm whether your product is affected.

What Triggered the Recall

The reason for the recall is a quality failure: testing found that the level of N-Nitroso-N-Desmethyl Diphenhydramine in the affected lots did not meet the required specification. Health Canada’s notice does not describe how the problem was found, and it does not report any illnesses or adverse reactions linked to the product.

The notice also does not give a specific health risk for this impurity, so this article does not speculate on one. Consumers with concerns about their health should speak with a healthcare provider.

Who Should Be Concerned

The distribution is national, so the affected lots could be in pharmacies and homes anywhere in Canada. The notice is aimed at the general public, healthcare professionals and industry. Anyone who has bought or been prescribed PDP-Diphenhydramine 25 mg capsules, or who stocks them, should check the lot numbers.

Because the recall reaches the retail level, pharmacies and other retailers holding these lots are also expected to act on it.

Steps Consumers Should Take

Health Canada’s guidance is brief and focused on checking your product and speaking with a professional before changing how you use it:

• Verify whether your product is affected by checking the lot number.
• Consult your healthcare provider before discontinuing use of the affected product, or if you have any health concerns.
• Contact the recalling firm if you have questions about the recall.
• Report any health product side effects to Health Canada.
• Report any other health product safety complaints to Health Canada.

Do not stop taking a medication without first speaking to a healthcare provider, since stopping could carry its own risks depending on why the product was being used.

Regulatory Response

The recall was published by Health Canada and is classified as a Type II health product recall. The notice recommends that consumers consult a healthcare provider before discontinuing use, rather than telling them to stop immediately.

The recalling firm is Pendopharm, a division of Pharmascience Inc., located at 6111 avenue Royalmount, suite 100, Montreal, Quebec, H4P 2T4. The notice does not give a phone number or email address for the company. Consumers can use the company address above or ask their pharmacist for help reaching the manufacturer.

Quick Facts

• Recall number: RA-82720
• Recall class: Type II
• Issue: Out-of-specification impurity (N-Nitroso-N-Desmethyl Diphenhydramine)
• Published: October 5, 2026
• Distribution: National (Canada)
• Depth of recall: Retailers

Consumers can sign up for email notifications about new and updated recalls on the Health Canada recalls website, and can report any health or safety concern through the Government of Canada’s reporting channels.