Health product recall
PDP-DIPHENHYDRAMINE 25 MG and 50 MG CAPSULES: Out-of-specification (Impurity)
Brand(s)
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
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- 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
Get notified
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Report a health or safety concern
- Date modified:
- 2026-11-09
Source: Originally published by Health Canada / Government of Canada.
Category: Health Products
Original alert: https://recalls-rappels.canada.ca/en/alert-recall/pdp-diphenhydramine-25-mg-and-50-mg-capsules-out-specification-impurity
Reproduced under the Open Government Licence – Canada.