Pendopharm pulls seven lots of diphenhydramine capsules across Canada over nitrosamine impurity

Pendopharm, the Montréal-based division of Pharmascience, has a national product withdrawal on its hands. Health Canada published the notice on 9 November 2026. It covers seven batches of PDP-DIPHENHYDRAMINE capsules across two strengths. The regulator says the nitrosamine impurity N-Nitroso-N-Desmethyl Diphenhydramine in these lots did not meet the product's specification.

The affected 25 mg capsules (DIN 00757683) come from lots 638997, 658003, 664380 and 669604. The 50 mg capsules (DIN 00757691) are affected in lots 653809, 658757 and 664907. The agency lists the action under reference RA-82928 as a Type II recall with national distribution. Its depth is retailer level, so the action reaches products held by retailers.

The notice contains nothing on the commercial side. It gives no unit volumes, sales value or financial exposure, and it does not say whether replacement stock is planned. It also omits the measured impurity level, the cause and any adverse events. It does record an earlier recall or alert for the 25 mg capsule involving an impurity that was outside specification, but offers no detail on that episode.

For patients, Health Canada advises checking whether their product is among the listed lots. They should talk to a healthcare provider before stopping use or if they have health concerns. They can contact the recalling firm with questions and report side effects or other safety complaints to the regulator.

As context, Health Canada's Type II category generally applies where a product may cause temporary or medically reversible adverse effects, or where the likelihood of serious harm is remote.