Apo-Fluoxetine Recalled Due to Impurities Out of Specification
Summary
Health Canada has issued a Type III health product recall for Apo-Fluoxetine 10mg and 20mg capsules by Apotex Inc. due to impurities being out of specification and out of trend. The recall affects retailer-level distribution. Affected lots include VM4608, VM4612 (20mg) and VM4598 (10mg). Patients with affected product should verify their medication and consult healthcare providers before making any changes to their treatment.
What changed
Health Canada has issued a Type III health product recall affecting Apo-Fluoxetine 10mg and 20mg capsules (lots VM4608, VM4612, VM4598) manufactured by Apotex Inc. The recall was initiated because impurities in the affected lots were found to be out of specification and out of trend. The recall depth is limited to retailers.
Healthcare providers and patients should verify whether any affected product is in their possession. Patients are advised to consult their healthcare provider before discontinuing use of the medication, as stopping fluoxetine without medical guidance may pose risks. Apotex Inc. should be contacted for recall procedures. Adverse reactions and quality concerns should be reported to Health Canada. This Type III classification indicates the probability of adverse health consequences is remote.
What to do next
- Verify if your product is from affected lots VM4608, VM4612 (20mg) or VM4598 (10mg)
- Consult your healthcare provider prior to discontinuing use of the affected product
- Report any adverse reactions or health product safety complaints to Health Canada
Archived snapshot
Apr 11, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
Apo-Fluoxetine: The impurities are out of specification and out of trend
Brand(s)
Last updated
2026-04-10
Summary
Product Apo-Fluoxetine Issue Health products - Product safety What to do Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns.
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot |
|---|---|---|---|---|---|
| Apotex | Apo-Fluoxetine 20mg | DIN 02216361 | Capsule | Fluoxetine (Fluoxetine hydrochloride) 20mg | VM4608, VM4612 |
| Apotex | Apo-Fluoxetine 10mg | DIN 02216353 | Capsule | Fluoxetine (Fluoxetine hydrochloride) 10mg | VM4598 |
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 information
Background
Depth of recall: Retailers
Details
Original published date:
2026-04-10
Alert / recall type Health product recall Category Health products - Drugs Companies
Apotex Inc.
150 Signet Drive
Toronto ON
M9L 1T9
Published by Health Canada Audience General public Healthcare Industry Recall class Type III Recall date
2026-04-10
Identification number RA-81883
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