The Recall Desk

Manufacturer

Apotex Inc.

42 recalls in our database name Apotex Inc. as the manufacturing or recalling firm.

What the numbers show

Total
42
Critical
1
Severe
19
Most recent
2020-06-24

Of the 42 recalls from Apotex Inc. we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (45%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 42

  • SevereFDA (Drugs)·D-1303-2020·2020-06-24

    Apotex Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Apotex Inc. is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0314-2020·2019-11-20

    Apotex Recalls Walgreens Wal-Zan 150 Tablets Due to NDMA Contamination Risk

    Apotex Inc. is recalling Walgreens Maximum Strength Wal-Zan 150 tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

    Product
    Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0319-2020·2019-11-20

    Rite Aid Ranitidine Tablets Recalled for Potential NDMA Contamination

    Apotex Inc. is recalling Rite Aid Pharmacy Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

    Product
    Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0315-2020·2019-11-20

    Apotex Recalls Walgreens Wal-Zan 75 Tablets Due to NDMA Contamination

    Apotex Inc. is recalling Walgreens Regular Strength Wal-Zan 75 tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

    Product
    Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0317-2020·2019-11-20

    Rite Aid Ranitidine Tablets Recalled for Possible NDMA Contamination

    Apotex Inc. is recalling Rite Aid Pharmacy Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

    Product
    Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4 Distributed By: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0318-2020·2019-11-20

    Apotex Recalls Equate Ranitidine Tablets Due to NDMA Contamination

    Apotex Inc. is recalling Equate Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA). The recall covers 162,344 bottles distributed nationwide.

    Product
    Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0316-2020·2019-11-20

    Apotex Recalls Equate Ranitidine Tablets Due to Possible NDMA Contamination

    Apotex Inc. is recalling Equate Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA). The recall covers 1,132,453 bottles distributed nationwide.

    Product
    Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0153-2020·2019-11-06

    Apotex Recalls Atorvastatin Calcium Tablets Due to Foreign Tablet Presence

    Apotex Inc. is recalling specific bottles of Atorvastatin Calcium 40 mg tablets because a single Pravastatin 40 mg tablet was found inside one bottle.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0992-2019·2019-03-13

    Apotex Recalls Out-of-Sequence Contraceptive Tablets

    Apotex Inc. is recalling specific lots of Drospirenone and Ethinyl Estradiol tablets because they may be missing or placed incorrectly in the blister pack.

    Product
    Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Pr
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0841-2018·2018-06-13

    Apotex Recalls Fluticasone Propionate Nasal Spray Due to Glass Particles

    Apotex Inc. is recalling Fluticasone Propionate Nasal Spray because glass particles were found in the product. Consumers should stop using the affected lot.

    Product
    FLUTICASONE PROPIONATE — FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0839-2018·2018-05-23

    Apotex Recalls Subpotent Piperacillin and Tazobactam Injection Vials

    Apotex Inc. is recalling 121,693 vials of Piperacillin and Tazobactam for Injection due to high impurity levels that decreased the drug's potency.

    Product
    Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0840-2018·2018-05-23

    Apotex Recalls Subpotent Piperacillin and Tazobactam Injection Vials

    Apotex Inc. is recalling specific lots of Piperacillin and Tazobactam for Injection due to high impurity levels that decreased the drug's potency.

    Product
    Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0475-2017·2017-03-01

    Apotex Recalls Cyclosporine Capsules Due to Impurity Failures

    Apotex Inc. is recalling 19,584 bottles of Cyclosporine Capsules, USP, 100 mg, because the product failed impurity specifications.

    Product
    CYCLOSPORINE — CYCLOSPORINE (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0471-2017·2017-02-15

    Apotex Recalls Aripiprazole Tablets Due to Potential Potency Issues

    Apotex Inc. is recalling 67,946 bottles of 2 mg Aripiprazole tablets because the product may not meet specifications throughout its shelf life.

    Product
    Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0009-2016·2015-10-21

    Apotex Recalls Bromfenac Ophthalmic Solution Due to Sterility Concerns

    Apotex Inc. is recalling specific lots of Bromfenac Ophthalmic Solution 0.09% because preservative testing failed, raising concerns about sterility.

    Product
    Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D1834-2015·2015-10-07

    Apotex Recalls Verapamil Hydrochloride Extended-Release Tablets for Dissolution Failure

    Apotex Inc. is recalling 2,075 bottles of Verapamil Hydrochloride Extended-Release tablets, 240 mg, because one lot failed to meet dissolution specification limits.

    Product
    Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex Research Private Limited, Bangalore, Karnataka 560 099, India; Manufactured for: Apotex Corp., Weston, FL 33326. NDC 60505-2742-5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1814-2015·2015-09-23

    Apotex Recalls Cevimeline Hydrochloride Capsules Due to Stability Failures

    Apotex Inc. is recalling Cevimeline Hydrochloride Capsules, 30 mg, because the product may not meet specification limits for assay testing.

    Product
    Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd., Bangalore, India, Manufactured for: Apotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1215-2015·2015-07-15

    Apotex Recalls Enalapril Maleate and Hydrochlorothiazide Tablets for Uniformity Issues

    Apotex Inc. is recalling 4,584 bottles of Enalapril maleate and hydrochlorothiazide tablets, 10/25 mg, because the product may not meet blend uniformity specifications.

    Product
    Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 56009
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1212-2015·2015-07-15

    Apotex Recalls Losartan Potassium Tablets Due to Uniformity Issues

    Apotex Inc. is recalling Losartan potassium tablets 25 mg because they may not meet blend uniformity specifications. The recall covers 45,708 bottles distributed nationwide, in Hawaii, and Puerto Rico.

    Product
    Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1213-2015·2015-07-15

    Apotex Recalls Losartan Potassium Tablets for Blend Uniformity Failure

    Apotex Inc. is recalling Losartan potassium tablets 100 mg because they may not meet blend uniformity specifications. The recall covers 23,178 bottles distributed nationwide, in Hawaii, and Puerto Rico.

    Product
    Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3162-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1214-2015·2015-07-15

    Apotex Recalls Losartan Potassium Tablets for Uniformity Issues

    Apotex Inc. is recalling 23,076 bottles of Losartan potassium tablets 50 mg because the product may not meet blend uniformity specifications.

    Product
    Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3161-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1080-2015·2015-05-20

    Apotex Recalls Subpotent Olanzapine Orally Disintegrating Tablets

    Apotex Inc. is voluntarily recalling 6,467 units of Olanzapine 10 mg orally disintegrating tablets because the drug is subpotent.

    Product
    Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1081-2015·2015-05-20

    Apotex Recalls Subpotent Olanzapine Orally Disintegrating Tablets

    Apotex Inc. is voluntarily recalling 5,352 bottles of Olanzapine 20 mg tablets because the drug was found to be subpotent.

    Product
    Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1079-2015·2015-05-20

    Apotex Recalls Subpotent Olanzapine Orally Disintegrating Tablets

    Apotex Inc. is voluntarily recalling specific lots of Olanzapine 5 mg orally disintegrating tablets because they contain less active drug than labeled.

    Product
    Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0487-2015·2015-04-22

    Apotex Recalls Bromfenac Ophthalmic Solution Due to CGMP Deviations

    Apotex Inc. is recalling 33,795 bottles of Bromfenac Ophthalmic Solution 0.09% because an excipient was not re-tested at the appropriate date.

    Product
    Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Apotex

Canadian private pharmaceutical company

Country
Canada
Founded
1974

Official website

Source: Wikidata (Q4780735), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.