Apotex Corp. recalls
Every recall we track for Apotex Corp. — 34 in all, from 2007–2026 — plus the complaints and injury reports the public filed about them. 3 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Apotex Corp. more than tripled in 2025 (6, up from 1 in 2024). 4% rated “stop using now”.
All FDA recall records for Apotex Corp. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 1 | 0 | 1 |
| 2021 | 0 | 0 | 2 | 1 | 3 |
| 2022 | 0 | 0 | 3 | 0 | 3 |
| 2023 | 0 | 1 | 1 | 4 | 6 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 3 | 1 | 2 | 6 |
| 2026 (to date) | 1 | 1 | 2 | 0 | 4 |
Apotex Corp. recalls before 2017
Recalls on record by year.
Most common reasons for Apotex Corp. recalls
What to do if you have a recalled Apotex Corp. product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All Apotex Corp. recalls
25 shown- Use cautionDrug
Apotex Corp. recalls Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario,
Apotex Corp. recalls specific lots of Paroxetine Extended-Release Tablets, 37.5mg, because they failed dissolution specifications.
ApotexSep 23, 2026 - Lower riskDrug
Apotex Corp. recalls Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc.,
Apotex recalls 37.5mg Paxil CR tablets due to failing 24-month stability tests. This may affect medication safety. Check your prescription bottle for NDC 60505-4379-3.
ApotexAug 13, 2026 - Lower riskDrug
Apotex Corp. recalls Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario,
Apotex recalls Desmopressin Nasal Spray (50 doses) due to defective bottle caps that may dislodge. This could cause the spray to leak or contaminate the product. Consumers should check their bottle's lot number and contact Apotex for details.
ApotexApr 8, 2026 - Stop using nowDrug
Apotex Corp. recalls Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured
Apotex recalls 5mL prescription eye drops (0.2%/0.5%) due to lack of sterility assurance. This could cause infections if used improperly. Check NDC 60505-0589-1 and lots VJ8599 or VL1668.
ApotexMar 5, 2026 - Use cautionDrug
Apotex Corp. recalls Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile,
Apotex recalls 0.2%/0.5% eye drops due to potential sterility issues from improper sealing. Affected lots expire Dec 2025. Stop using if you have these specific sizes.
ApotexSep 5, 2025 - Use cautionDrug
Apotex Corp. recalls Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L
Apotex recalls 10 mg/mL Lacosamide Oral Solution (200mL) due to leaking when stored horizontally. This prescription drug may cause medication exposure risks if the container leaks.
ApotexMay 28, 2025 - UnratedDrug
Apotex Corp. recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario,
Apotex recalls Ketorolac 0.5% eye drops due to lack of sterility assurance. This could cause infections. Check NDC 60505-1003-2, batch TZ1236, exp 11/30/2025.
ApotexMay 28, 2025 - Lower riskDrug
Apotex Corp. recalls Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc.
Apotex recalls Fluticasone Propionate Nasal Spray 50mcg 120 sprays due to potential Burkholderia cepacia contamination. This may pose health risks for users with compromised immune systems.
ApotexFeb 9, 2024 - UnratedDrug
Apotex Corp. recalls Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle,
Apotex recalls 30mg Paroxetine Hydrochloride tablets (NDC 60505-0084-1, 60505-0084-2, 60505-0084-4) due to impurities. These prescription antidepressants may have unsafe chemical levels that could cause harm.
ApotexNov 1, 2023 - Lower riskDrug
Apotex Corp. recalls Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon
Apotex recalls nasal spray with glass splinter risk. Foreign particles in pump may cause malfunction. Stop using immediately if affected.
ApotexApr 26, 2023 - Use cautionDrug
Apotex Corp. recalls Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3
Apotex recalls Brimonidine Tartrate Ophthalmic Solution 0.15% (Rx only) due to cap cracks that may compromise sterility. Affected units have specific NDC/UPC codes and expiration dates. Consumers should contact Apotex for details.
ApotexMar 1, 2023 - Lower riskDrug
Apotex Corp. recalls Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg
Apotex recalls Timolol Maleate Ophthalmic Solution 0.5% 2.5mL (Rx only) due to stability issues. Product may lose effectiveness over time, but no immediate safety risk.
ApotexDec 21, 2022 - Lower riskDrug
Apotex Corp. recalls Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count
Apotex recalls 20mg Aripiprazole tablets due to failed dissolution testing at 12 months. This may affect medication effectiveness. Check NDC codes for affected batches.
ApotexJul 7, 2022 - Lower riskDrug
Apotex Corp. recalls Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9
Apotex recalls Sirolimus Oral Solution (1 mg/mL, 60mL) due to failed dissolution specifications in one lot. This may affect medication effectiveness. Check your product details to see if it's affected.
ApotexMay 3, 2022 - UnratedDrug
Apotex Corp. recalls Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario
Apotex recalls 2mg Guanfacine Extended-Release Tablets due to trace quetiapine fumarate contamination. Affected lots expire Nov 2022. No action needed per official notice.
ApotexMar 31, 2021 - Lower riskDrug
Apotex Corp. recalls Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection
Apotex recalls 10x1mL Enoxaparin syringes with incorrect labeling that may cause dosing errors. Affected units have 150mg/mL markings instead of 100mg/mL. Contact for return instructions.
ApotexFeb 2, 2021 - Lower riskDrug
Apotex Corp. recalls Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC
Apotex recalls 15mg Aripiprazole tablets that failed dissolution tests. These prescription-only pills may not release medication properly. Consumers should contact Apotex for details.
ApotexNov 11, 2020 - UnratedDrug
Apotex Corp. recalls Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3,
Apotex recalls 5mg Torsemide tablets due to manufacturing deviations. This may affect safety in normal use. Check your product details to see if you are affected.
ApotexDec 14, 2016 - Use cautionDrug
Apotex Corp. recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex
Apotex recalls 90-count bottles of Candesartan Cilexetil and Hydrochlorothiazide tablets due to high levels of a degradant impurity.
ApotexAug 21, 2014 - Use cautionDrug
Apotex Corp. recalls Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario
Apotex recalls specific lots of Olanzapine Orally Disintegrating Tablets because they may be subpotent. Check your bottle's lot number and expiration date.
ApotexApr 18, 2014 - Stop using nowDrug
Apotex Corp. recalls Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira
Apotex recalls 52,398 vials of Piperacillin and Tazobactam for Injection due to potential crystallization. Check lot numbers 503B023-503C020.
ApotexMay 10, 2013 - Stop using nowDrug
Apotex Corp. recalls Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira
Apotex recalls specific lots of Piperacillin and Tazobactam for Injection due to potential crystallization. Check lot numbers and expiration dates immediately.
ApotexMar 18, 2013 - UnratedDrug
Apotex Corp. recalls Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560
Apotex Corp. recalls one lot of 15 mg Meloxicam tablets due to a slightly oversized tablet. Check your bottle's lot number and expiration date.
ApotexApr 5, 2012 - Use cautionDrug
Apotex Corp. recalls Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc.,
Apotex recalls 963,407 bottles of Azelastine HCl Nasal Solution due to potential tubing interaction. Check lot numbers JK9130, JM0925, JN6514, JN1125, JN1127, JR5780, JR5782.
ApotexJun 15, 2011 - Lower riskDrug
Apotex Corp. recalls Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only,
Apotex recalls 10mg leflunomide tablets (30-count and 1000-count bottles) due to subpotent quality. These prescription drugs may not meet strength specifications.
ApotexJun 14, 2007
Apotex Corp. recall questions
How many recalls has Apotex Corp. had?
34 recalls from Apotex Corp. are on record with U.S. safety agencies, from 2007–2026.
What is the most recent Apotex Corp. recall?
Apotex Corp. recalls Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario,, dated Sep 23, 2026. Every Apotex Corp. recall is listed on this page, newest first.
Why are Apotex Corp. products recalled?
The most common reasons on record: Lack of Assurance of Sterility (4); CGMP Deviations (2).
What should I do if I have a recalled Apotex Corp. product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new Apotex Corp. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.