PDP-DIPHENHYDRAMINE 25 MG and 50 MG CAPSULES: Out-of-specification (Impurity)

Health product recall

PDP-DIPHENHYDRAMINE 25 MG and 50 MG CAPSULES: Out-of-specification (Impurity)

 

Brand(s)

Pendopharm

Last updated

2026-11-09

Summary

Product

PDP-DIPHENHYDRAMINE

Issue

Health products – Product quality

What to do

Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns.

Distribution

National

Affected products

Brand	Product Name	Market Authorization	Dosage Form	Strength	Lot Number
Pendopharm	PDP-DIPHENHYDRAMINE	DIN 00757683	Capsule	25 MG	638997 658003 664380 669604
Pendopharm	PDP-DIPHENHYDRAMINE	DIN 00757691	Capsule	50 MG	653809 658757 664907

Issue

The impurity, N-Nitroso-N-Desmethyl Diphenhydramine, is out of specification in the affected lots.

What you should do

1. Verify if your product is affected.
2. Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns.
3. Contact the recalling firm if you have any questions about the recall.
4. Report any health product related side effects to Health Canada.
5. Report any other health product safety complaints to Health Canada.

Additional information

Previous recalls or alerts

PDP-DIPHENHYDRAMINE 25 MG CAPSULE: Out-of-specification (Impurity)

Background

Depth of Recall: Retailers

Details

Original published date: 2026-11-09

Alert / recall type

Health product recall

Category

Health products – Drugs

Companies

Pendopharm Division of Pharmascience Inc.
6111 avenue Royalmount, suite 100

Montréal, QC H4P 2T4

Published by

Health Canada

Audience

General public
Healthcare
Industry

Distribution

National

Recall class

Type II

Identification number
RA-82928

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Date modified:

2026-11-09