Public recall detail

Apo-Fluoxetine: The impurities are out of specification and out of trend

2026-04-10

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Drugs Product safety
Quick summary

Quick summary: Apo-Fluoxetine: The impurities are out of specification and out of trend. Reason: Product safety. Category: Drugs. Date: 2026-04-10.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Apo-Fluoxetine: The impurities are out of specification and out of trend. Reason: Product safety. Category: Drugs. Date: 2026-04-10.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandApotex Inc., Apotex
ProductApo-Fluoxetine
IssueHealth products - Product safety
Recall classType III
IdentificationRA-81883

Affected products

BrandApotex
ProductApo-Fluoxetine 20mg
DIN / NPN / authorizationDIN 02216361
Dosage formCapsule
StrengthFluoxetine (Fluoxetine hydrochloride) 20mg
LotVM4608, VM4612
BrandApotex
ProductApo-Fluoxetine 10mg
DIN / NPN / authorizationDIN 02216353
Dosage formCapsule
StrengthFluoxetine (Fluoxetine hydrochloride) 10mg
LotVM4598

Issue

The impurities are out of specification and out of trend in the affected lot.

What you should do

  • Verify if your product is affected.
  • Consult your healthcare provider prior to discontinuing use of the affected product(s), 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 official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Drugs
CompaniesApotex Inc. 150 Signet Drive Toronto ON M9L 1T9
Recall date2026-04-10
Published byHealth Canada
Recall classType III
Alert / recall typeHealth product recall
Identification numberRA-81883
Background{}
CompaniesApotex Inc. 150 Signet Drive Toronto ON M9L 1T9
AudiencesGeneral public Healthcare Industry
Source updated2026-04-10

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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