Apotex Corp. — FDA Facility Profile
Apotex Corp. is an FDA-inspected facility (FEI 3006727872) located in Weston, FL, US. RegDataLab tracks 1 FDA inspection at this facility.
Reviewing Apotex Corp. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Apotex Corp. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
What FDA found at this site
- Latest inspection
- Aug 10, 2011: Voluntary Action Indicated (VAI)
- Inspections on record
- 1 (1 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 31, latest Sep 23, 2026
- Import refusals
- 6
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 10, 2011 | Voluntary Action Indicated (VAI) | Late submission of 15-day report (21 CFR 314.80(c)(1)(i)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Sep 23, 2026 | Class II | D-0877-2026 | Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by… Failed dissolution specifications. |
| Aug 13, 2026 | Class II | D-0804-2026 | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only… Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria |
| Apr 8, 2026 | Class II | D-0510-2026 | Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by… Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners. |
| Mar 5, 2026 | Class II | D-0407-2026 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only… Lack of Assurance of Sterility |
| Sep 5, 2025 | Class II | D-0676-2025 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL… and 1 more product Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns |
| May 28, 2025 | Class II | D-0457-2025 | Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc… Defective Container: This recall is being initiated due to a leaking unit stored horizontally. |
| May 28, 2025 | Class II | D-0494-2025 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex… and 2 more products Lack of Assurance of Sterility |
| Feb 9, 2024 | Class II | D-0326-2024 | Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx… CGMP Deviations: potential presence of Burkholderia cepacia complex |
| Nov 1, 2023 | Class II | D-0119-2024 | Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#… and 3 more products Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine |
| Apr 26, 2023 | Class II | D-0568-2023 | Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200… Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable. |
Facility details
- Company
- Apotex Corp.
- Location
- Weston, FL (US)
- Source
- inspections