Generic drug makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 7 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Apotex and its 2 subsidiaries with 395 drug applications, 79 drug recalls, 2 warning letters and 1 510(k) clearance. The most recent is a warning letter dated Oct 31, 2025: Warning letter: Aseptic processing, Sterility assurance, Cleaning validation.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Apotex and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 31, 2025 | Warning letter: Aseptic processing, Sterility assurance, Cleaning validationCDER | Warning letters |
| Aug 9, 2018 | Warning letter: Process validation, Out-of-specification, Quality unitCDER | Warning letters |
| Jun 25, 2013 | Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L Class II · Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be | Drug recalls |
| Aug 10, 1993 | ANA PROFILE IK932424 · LJM | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
