Apotex recalls
FDA enforcement reports naming Apotex Corp. as the recalling firm.
- Recall reports
- 75
- Class I (serious)
- 6
- Most recent report
- Sep 2, 2026
- Sep 2, 2026Paxil CR, Paroxetine, Extended-Release Tablets, 37Drug · Apotex Corp.Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteriaClass II
- Apr 22, 2026Desmopressin Nasal Spray, USP, 10 mcg/0Drug · Apotex Corp.Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.Class II
- Mar 25, 2026Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0Drug · Apotex Corp.Lack of Assurance of SterilityClass II
- Oct 8, 2025Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0Drug · Apotex Corp.Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concernsClass II
- Oct 8, 2025Ketorolac Tromethamine Ophthalmic Solution, 0Drug · Apotex Corp.Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concernsClass II
- Jul 2, 2025Ketorolac Tromethamine Ophthalmic Solution, 0Drug · Apotex Corp.Lack of Assurance of SterilityClass II
- Jul 2, 2025Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0Drug · Apotex Corp.Lack of Assurance of SterilityClass II
- Jul 2, 2025Azelastine HCl Ophthalmic Solution, USP, 0Drug · Apotex Corp.Lack of Assurance of SterilityClass II
- Jun 11, 2025Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex IncDrug · Apotex Corp.Defective Container: This recall is being initiated due to a leaking unit stored horizontally.Class II
- Feb 28, 2024Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx O…Drug · Apotex Corp.CGMP Deviations: potential presence of Burkholderia cepacia complexClass II
- Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle
- Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle
- Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle
- Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle
- Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL,…
- Brimonidine Tartrate Ophthalmic Solution 0
- Timolol Maleate Ophthalmic Solution, USP 0
- Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8
- Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc
- Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: A…
- Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety D…
- Enoxaparin Sodium Injection, USP 120 mg/ 0
- Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Onl…
- Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distrib…
- Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Dist…
- Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tab…
- Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reduce…
- Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets S…
- Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distribu…
- Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by…
- Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0
- Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Meter…
- Piperacillin and Tazobactam for Injection, USP 3
- Piperacillin and Tazobactam for Injection, USP 4
- CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc
- Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc
- Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc
- Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc
- Bromfenac Ophthalmic Solution 0
- Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx On…
- Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle,…
- Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apot…
- Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apot…
- Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apote…
- Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx o…
- Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03…
- Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufacture…
- Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03)…
- Bromfenac Ophthalmic Solution 0
- Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex R…
- Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex R…
- Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count…
- Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count…
- Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured b…
- Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12
- PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSm…
- PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSm…
- PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37
- Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured…
- PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSm…
- Paroxetine HCL Controlled-Release Tablets 12
- PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactur…
- Paroxetine HCL Controlled-Release Tablets 37
- PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, M…
- Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc
- Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc
- Piperacillin and Tazobactam for Injection, USP, 40
- Latanoprost Ophthalmic Solution, 0
- Piperacillin and Tazobactam for Injection, USP, 40
- Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle…
- Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp
- Azelastine HCl Nasal Solution, 0
- Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Stride…
- Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22
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