Quality & complianceOfficial

Pendopharm recalls diphenhydramine capsules in Canada over out-of-specification nitrosamine impurity

🇨🇦 Health Canada · Mon 09 Nov 2026

Health Canada reports a Type II national recall of Pendopharm's 25 mg and 50 mg diphenhydramine capsules after N-Nitroso-N-Desmethyl Diphenhydramine exceeded specification in seven lots.

Health Canada published a recall notice on 9 November 2026 for PDP-DIPHENHYDRAMINE capsules, marketed by Pendopharm, a division of Pharmascience Inc. in Montréal. The agency says the impurity N-Nitroso-N-Desmethyl Diphenhydramine is out of specification in the affected lots.

The recall covers two presentations. The 25 mg capsules (DIN 00757683) are affected in lots 638997, 658003, 664380 and 669604. The 50 mg capsules (DIN 00757691) are affected in lots 653809, 658757 and 664907.

The recall is classed as Type II and has national distribution. Its depth is at retailer level. It is listed under identification number RA-82928. The notice also lists a previous recall or alert for PDP-DIPHENHYDRAMINE 25 MG CAPSULE for an out-of-specification impurity, but gives no further detail on it.

Health Canada advises people to check whether their product is affected and to consult a healthcare provider before stopping use of the product or if they have health concerns. Consumers can contact the recalling firm with questions and report side effects or other safety complaints to Health Canada. The notice does not state the measured impurity level, the cause, or any reported adverse events.

For context, a Type II recall in Canada generally applies where use of a product may cause temporary or medically reversible adverse effects, or where the probability of serious harm is remote.

What it means for your team

  • Quality and supply teams should check holdings against the seven listed lot numbers and both DINs (00757683 and 00757691).
  • The notice gives no impurity level, root cause or acceptance limit, so companies should look to the recalling firm or Health Canada for further detail.
  • Nitrosamine-related drug substance-related impurity (NDSRI) controls remain a live compliance topic for finished-product specifications and testing.
  • Pharmacovigilance teams may wish to monitor for related safety reports, as Health Canada is asking for side effects to be reported.

Official source: Health Canada ↗

Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.

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