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Health Canada nitrosamine recalls and MHRA MOVICOL recall — 6 October 2026

  • 06-10-2026
  • Posted by: Eldaniz Hasanov
  • Category: Regulatory Updates
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Health Canada published three related Type II recalls of carvedilol 25 mg tablets because N-nitroso-carvedilol may be out of specification. The actions cover 43 lots of Sanis, PMS-Carvedilol and Pro Doc products.

Carvedilol recalls: 43 affected lots

Patients should verify whether their lot is affected and consult a healthcare professional before discontinuing treatment or if they have health concerns.

Diphenhydramine recall: six affected lots

Health Canada recall RA-82720 covers six lots of PDP-DIPHENHYDRAMINE 25 mg capsules because N-Nitroso-N-Desmethyl Diphenhydramine is out of specification.

MHRA Class 3 recall: MOVICOL Plain

MHRA notification EL(26)A/41 / DMRC-40129134 covers MOVICOL Plain 13.7 g batches 487069 and 474919 because some units may contain incorrect amounts of active ingredients. Pharmacies, wholesalers and retailers should stop supply, quarantine remaining stock and return it through the approved process. MHRA states that patients in possession of the affected batches may continue taking the medicine.

Relevance for pharmacovigilance teams

For QPPV, LQPPV and LPPV teams, these actions support local impact assessment, lot reconciliation, case monitoring, stakeholder communication and alignment between quality-defect and pharmacovigilance processes.

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on the official communications issued by Health Canada and MHRA and current as of 6 October 2026. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by the manufacturers/marketing authorisation holders or a quality concern affecting the companies’ entire product portfolios. Company and product names are used only to identify the official materials accurately. Decisions should be based on the primary sources, the regulators’ instructions and the approved product information.