Drug establishmentActive, Registered FY2026FDA warning letter on file
Apotex Inc.
Apotex Inc. is an FDA-registered drug establishment (FEI 3002808376) located in . The facility is active, registered for FY2026. FDA has issued 1 warning letter(s) to this facility.
FDA warning letter
Oct 31, 2025CGMP/Finished Pharmaceuticals/Adulterated
A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.
Recalls (8)
Apr 8, 2026 Class IIDefective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Ongoing
Mar 5, 2026 Class IILack of Assurance of Sterility
Ongoing
Sep 5, 2025 Class IILack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Ongoing
May 28, 2025 Class IILack of Assurance of Sterility
Ongoing
Nov 1, 2023 Class IIFailed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Ongoing
Mar 1, 2023 Class IILack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Completed
Jul 7, 2022 Class IIFailed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Terminated
May 3, 2022 Class IIIFailed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Terminated
Recall data from openFDA enforcement reports (FDA Recall Enterprise System).
Establishment record
Address
50 Steinway Blvd., ,
Establishment type
Drug establishment
Products / operations
ANALYSIS; MANUFACTURE
Registration status
Active, Registered FY2026
Verify this record on FDA.gov ›
Inspection history
Inspections on file
None on file
Form 483 observations
None on file
FDA publishes only a subset of inspection records and Form 483s, so "None on file" is not a guarantee of a clean inspection history.
Questions
Is Apotex Inc. registered with the FDA?
Yes. Apotex Inc. is an FDA-registered drug establishment (FEI 3002808376) in . Its current registration status is Active, Registered FY2026.
Has Apotex Inc. received an FDA warning letter?
Yes. FDA issued a warning letter to Apotex Inc.; the most recent is dated Oct 31, 2025 (CGMP/Finished Pharmaceuticals/Adulterated).
What does Apotex Inc. do?
Apotex Inc.'s FDA-registered operations are: ANALYSIS; MANUFACTURE.
Source: FDA public data · status as of 2026-06-01