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Manufacturer profile

Apotex Corp.

Pharmaceutical company12 products tracked
12
products tracked
324,115
total reports
34
recalls on record
68.3%
serious overall
Products
showing 12 of 12
ProductApprovedReports ↓Top signalRecalls
2004122,601Myelosuppression8
199289,618Drug exposure during pregnancy4
200240,362Chronic kidney disease0
200223,432Blepharospasm0
199615,696Encephalopathy19
19939,240Lymphocyte count decreased0
20087,266Parkinsonism0
20145,765Middle insomnia0
19844,243Amaurosis fugax1
20112,335Clostridium difficile infection1
20032,290Hepatic cytolysis1
20021,267Hypophosphataemic osteomalacia0
Recall history · 50 on record
DateClassReasonFirm
Apr 8, 2026IIDefective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.Apotex Corp.
Mar 5, 2026IILack of Assurance of SterilityApotex Corp.
Sep 5, 2025IILack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concernsApotex Corp.
Sep 5, 2025IILack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concernsApotex Corp.
May 28, 2025IILack of Assurance of SterilityApotex Corp.
May 28, 2025IILack of Assurance of SterilityApotex Corp.
May 28, 2025IILack of Assurance of SterilityApotex Corp.
May 28, 2025IIDefective Container: This recall is being initiated due to a leaking unit stored horizontally.Apotex Corp.
Feb 9, 2024IICGMP Deviations: potential presence of Burkholderia cepacia complexApotex Corp.
Nov 1, 2023IIFailed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of ParoxetineApotex Corp.
Nov 1, 2023IIFailed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of ParoxetineApotex Corp.
Nov 1, 2023IIFailed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of ParoxetineApotex Corp.
Nov 1, 2023IIFailed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of ParoxetineApotex Corp.
May 15, 2023IILack of Assurance of SterilityAstral SteriTech Private Ltd.
May 15, 2023IILack of Assurance of SterilityAstral SteriTech Private Ltd.
May 15, 2023IILack of Assurance of SterilityAstral SteriTech Private Ltd.
May 15, 2023IILack of Assurance of SterilityAstral SteriTech Private Ltd.
May 15, 2023IILack of Assurance of SterilityAstral SteriTech Private Ltd.
May 15, 2023IILack of Assurance of SterilityAstral SteriTech Private Ltd.
May 15, 2023IILack of Assurance of SterilityAstral SteriTech Private Ltd.
Apr 26, 2023IIPresence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.Apotex Corp.
Mar 1, 2023IILack 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.Apotex Corp.
Dec 27, 2022IILack of sterility assuranceSentara Infusion Services
Jul 7, 2022IIFailed dissolution specifications: OOS for dissolution at the 12-month stability time point.Apotex Corp.
May 3, 2022IIIFailed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.Apotex Corp.
Mar 31, 2021IICross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine FumarateApotex Corp.
Feb 2, 2021ILabeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)Apotex Corp.
Feb 2, 2021ILabeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)Apotex Corp.
Nov 11, 2020IIFailed Dissolution Specifications: Out of specification for dissolution.Apotex Corp.
Jun 12, 2019IILack of Assurance of SterilityInfusion Options, Inc.
Feb 9, 2018IICGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.American Pharmaceutical Ingredients LLC
Nov 10, 2015IILack of Assurance of SterilityWalgreens Infusion Services
Sep 18, 2015IILack of Assurance of Sterility: Product sterility cannot be guaranteed.Sentara Enterprises
May 28, 2015IILack of Assurance of Sterility: Sterility of product is not assuredLincare, Inc.
May 28, 2015IILack of Assurance of Sterility: Sterility of product is not assured.Lincare, Inc.
May 28, 2015IILack of Assurance of Sterility: Sterility of product is not assured.Lincare, Inc.
Mar 18, 2015IPresence of Particulate MatterMylan Institutional LLC
Nov 14, 2014IIPenicillin Cross Contamination: All lots of all products repackaged between 01/05/12 through 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.Attix Pharmaceuticals
Aug 21, 2014IIIFailed Impurity/Degradation Specification; high out of specification for CAD II degradantApotex Corp.
May 15, 2014IILack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014IILack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014IILack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.Franck's Lab Inc dba Trinity Care Solutions
Apr 18, 2014IIISubpotent Drug: Out of specification (OOS) results at the 9 month temperature point.Apotex Corp.
Nov 21, 2013IPresence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.B. Braun Medical Inc
Oct 15, 2013IPresence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.B. Braun Medical Inc
Aug 13, 2013IILack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.Teva Pharmaceuticals USA, Inc.
Jul 2, 2013IILabeling: Label Mixup; FIDAXOMICIN Tablet, 200 mg may be potentially mislabeled as BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: W003918, EXP: 6/28/2014.Aidapak Services, LLC
May 10, 2013ICrystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.Apotex Corp.
Mar 18, 2013ICrystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.Apotex Corp.
Nov 8, 2012ICrystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.Hospira Inc.

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.

Registration status

Some products from Apotex Corp. are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.