Recalls by year
12
13
14
15
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 13, 2019DrugsFDA
Apotex Inc. recalls Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as
Hazard: Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
June 13, 2018DrugsFDA
Apotex Inc. recalls Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill
Hazard: Presence of foreign substance: glass particles
May 23, 2018DrugsFDA
Apotex Inc. recalls Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Ho
Hazard: Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
May 23, 2018DrugsFDA
Apotex Inc. recalls Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by:
Hazard: Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
March 1, 2017DrugsFDA
Apotex Inc. recalls CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Ma
Hazard: Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
February 15, 2017DrugsFDA
Apotex Inc. recalls Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; M
Hazard: Superpotent Drug: Product may not meet specifications throughout shelf life.
January 11, 2017DrugsFDA
Apotex Corp. recalls Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Man
Hazard: CGMP Deviations
January 11, 2017DrugsFDA
Apotex Corp. recalls Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Ma
Hazard: CGMP Deviations
October 21, 2015DrugsFDA
Apotex Inc. recalls Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-
Hazard: Lack of Assurance of Sterility: Failed preservative effectiveness testing
October 7, 2015DrugsFDA
Apotex Inc. recalls Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by
Hazard: Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
September 23, 2015DrugsFDA
Apotex Inc. recalls Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex
Hazard: Failed Stability Specifications: product may not meet specification limit for assay test.
July 15, 2015DrugsFDA
Apotex Inc. recalls Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc
Hazard: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
July 15, 2015DrugsFDA
Apotex Inc. recalls Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9
Hazard: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
July 15, 2015DrugsFDA
Apotex Inc. recalls Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T
Hazard: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
July 15, 2015DrugsFDA
Apotex Inc. recalls Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T
Hazard: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
May 20, 2015DrugsFDA
Apotex Inc. recalls Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario
Hazard: Subpotent drug
May 20, 2015DrugsFDA
Apotex Inc. recalls Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 6050
Hazard: Subpotent drug
May 20, 2015DrugsFDA
Apotex Inc. recalls Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505
Hazard: Subpotent drug
April 22, 2015DrugsFDA
Apotex Inc. recalls Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle,
Hazard: CGMP Deviations: Product excipient was not re-tested at the appropriate date.
November 12, 2014DrugsFDA
Apotex Inc. recalls Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx On
Hazard: Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
November 12, 2014DrugsFDA
Apotex Inc. recalls Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx On
Hazard: Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
November 12, 2014DrugsFDA
Apotex Inc. recalls Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560
Hazard: Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
November 12, 2014DrugsFDA
Apotex Inc. recalls Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560
Hazard: Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
October 1, 2014DrugsFDA
Apotex Corp. recalls Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Ca
Hazard: Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
September 24, 2014DrugsFDA
Apotex Corp. recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex
Hazard: Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
September 10, 2014DrugsFDA
Apotex Inc. recalls PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufact
Hazard: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
September 10, 2014DrugsFDA
Apotex Inc. recalls PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufact
Hazard: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
September 10, 2014DrugsFDA
Apotex Inc. recalls PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufact
Hazard: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
September 10, 2014DrugsFDA
Apotex Inc. recalls PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline,
Hazard: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
September 10, 2014DrugsFDA
Apotex Inc. recalls PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, R
Hazard: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.