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.

26–42 of 42

  • ModerateFDA (Drugs)·D-0241-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling Candesartan Cilexetil Tablets, 4 mg, because out-of-specification results were observed for specific impurities and total impurities.

    Product
    Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0244-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling Candesartan Cilexetil Tablets, 32 mg, because out-of-specification results were observed for specific impurities and total impurities.

    Product
    Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0242-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling specific lots of Candesartan Cilexetil Tablets because they failed impurity and degradation specifications.

    Product
    Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0243-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling Candesartan Cilexetil Tablets, 16 mg, because out-of-specification results were observed for specific impurities and total impurities.

    Product
    Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1578-2014·2014-09-10

    Apotex Recalls PAXIL CR Tablets Due to Chemical Contamination

    Apotex Inc. is recalling PAXIL CR tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.

    Product
    PAXIL — PAXIL (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1575-2014·2014-09-10

    Apotex Recalls PAXIL Oral Suspension Due to Chemical Contamination

    Apotex Inc. is recalling PAXIL (Paroxetine HCL) Oral Suspension because it was manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.

    Product
    PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1581-2014·2014-09-10

    Apotex Recalls PAXIL Tablets Due to Chemical Contamination

    Apotex Inc. is recalling specific lots of PAXIL (Paroxetine HCL) 20 mg tablets because they were manufactured with active pharmaceutical ingredients contaminated with residual materials and solvents.

    Product
    PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3664-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1574-2014·2014-09-10

    Apotex Recalls Paroxetine Hydrochloride Tablets Due to Chemical Contamination

    Apotex Inc. is recalling Paroxetine Hydrochloride Controlled-Release Tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.

    Product
    PAROXETINE HYDROCHLORIDE — PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1582-2014·2014-09-10

    Apotex Recalls PAXIL Tablets Due to Chemical Contamination

    Apotex Inc. is recalling PAXIL (Paroxetine HCL) 40 mg tablets due to contamination with residual materials and solvents.

    Product
    PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3666-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1577-2014·2014-09-10

    Apotex Recalls Paroxetine Hydrochloride Tablets Due to Chemical Contamination

    Apotex Inc. is recalling specific lots of Paroxetine Hydrochloride Controlled-Release Tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.

    Product
    PAROXETINE HYDROCHLORIDE — PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1580-2014·2014-09-10

    Apotex Recalls PAXIL Tablets Due to Chemical Contamination

    Apotex Inc. is recalling PAXIL (Paroxetine HCL) 10 mg tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.

    Product
    PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3663-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1579-2014·2014-09-10

    Apotex Recalls PAXIL Tablets Due to Chemical Contamination

    Apotex Inc. is recalling PAXIL CR tablets because they were manufactured with active pharmaceutical ingredients contaminated with residual materials and solvents.

    Product
    PAXIL — PAXIL (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1576-2014·2014-09-10

    Apotex Recalls Paroxetine Hydrochloride Tablets Due to Chemical Contamination

    Apotex Inc. is recalling Paroxetine Hydrochloride Controlled-Release Tablets 25 mg because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.

    Product
    PAROXETINE HYDROCHLORIDE — PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1299-2014·2014-05-07

    Apotex Recalls Risperidone Oral Solution Due to Impurity Specification Failure

    Apotex Inc. is recalling Risperidone Oral Solution because it failed impurity specifications at the 18-month stability time point.

    Product
    Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-852-2013·2013-08-14

    Apotex Recalls Latanoprost Ophthalmic Solution Due to Sterility Concerns

    Apotex Inc. is recalling Latanoprost Ophthalmic Solution, 0.005%, because it failed a preservative effectiveness test, raising concerns about potential microbial growth.

    Product
    Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1439-2012·2012-08-08

    Apotex Recalls Dorzolamide HCI/Timolol Maleate Ophthalmic Solution Due to Particulates

    Apotex Inc. is recalling specific lots of Dorzolamide HCI/Timolol Maleate Ophthalmic Solution because they may contain small particulates.

    Product
    Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
    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.