Apotex Inc.
Complete recall history across all FDA and CPSC categories — 41 total recalls
Apotex Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (41)
FDA drug safety enforcement actions by Apotex Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| May 27, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottl... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity... | Class II |
| Oct 22, 2019 | Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manuf... | Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg fo... | Class III |
| Sep 24, 2019 | Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Re... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine ... | Class II |
| Sep 24, 2019 | Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Redu... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine ... | Class II |
| Sep 24, 2019 | Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reduce... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine ... | Class II |
| Sep 24, 2019 | Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint A... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine ... | Class II |
| Sep 24, 2019 | Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine ... | Class II |
| Sep 24, 2019 | Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Table... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine ... | Class II |
| Mar 1, 2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Bli... | Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. | Class II |
| May 31, 2018 | Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray... | Presence of foreign substance: glass particles | Class II |
| May 8, 2018 | Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Sing... | Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency | Class I |
| May 8, 2018 | Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single... | Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency | Class I |
| Feb 3, 2017 | CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by... | Failed Impurities/Degradations Specifications; out of specification results f... | Class II |
| Dec 19, 2016 | Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex... | Superpotent Drug: Product may not meet specifications throughout shelf life. | Class III |
| Aug 25, 2015 | Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-... | Lack of Assurance of Sterility: Failed preservative effectiveness testing | Class II |
| Aug 17, 2015 | Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 cou... | Failed Stability Specifications: product may not meet specification limit for... | Class II |
| Jul 21, 2015 | Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bott... | Failed Dissolution Specification: One lot of product did not meet the first s... | Class III |
| May 29, 2015 | Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured... | Failed Content Uniformity Specifications: The product may not meet the limit ... | Class II |
| May 29, 2015 | Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufacture... | Failed Content Uniformity Specifications: The product may not meet the limit ... | Class II |
| May 29, 2015 | Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufacture... | Failed Content Uniformity Specifications: The product may not meet the limit ... | Class II |
| May 29, 2015 | Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bo... | Failed Content Uniformity Specifications: The product may not meet the limit ... | Class II |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 6050... | Subpotent drug | Class III |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 605... | Subpotent drug | Class III |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, M... | Subpotent drug | Class III |
| Feb 12, 2015 | Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, ... | CGMP Deviations: Product excipient was not re-tested at the appropriate date. | Class III |
| Oct 16, 2014 | Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured b... | Failed Impurities/Degradation Specifications: Out of specification (OOS) resu... | Class III |
| Oct 16, 2014 | Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b... | Failed Impurities/Degradation Specifications: Out of specification (OOS) resu... | Class III |
| Oct 16, 2014 | Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b... | Failed Impurities/Degradation Specifications: Out of specification (OOS) resu... | Class III |
| Oct 16, 2014 | Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured b... | Failed Impurities/Degradation Specifications: Out of specification (OOS) resu... | Class III |
| Mar 24, 2014 | Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, ... | Chemical Contamination: Product were manufactured with active pharmaceutical ... | Class II |
| Mar 24, 2014 | PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured ... | Chemical Contamination: Product were manufactured with active pharmaceutical ... | Class II |
| Mar 24, 2014 | PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, ... | Chemical Contamination: Product were manufactured with active pharmaceutical ... | Class II |
| Mar 24, 2014 | PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, ... | Chemical Contamination: Product were manufactured with active pharmaceutical ... | Class II |
| Mar 24, 2014 | Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, ... | Chemical Contamination: Product were manufactured with active pharmaceutical ... | Class II |
| Mar 24, 2014 | PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle... | Chemical Contamination: Product were manufactured with active pharmaceutical ... | Class II |
| Mar 24, 2014 | PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured ... | Chemical Contamination: Product were manufactured with active pharmaceutical ... | Class II |
| Mar 24, 2014 | PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured ... | Chemical Contamination: Product were manufactured with active pharmaceutical ... | Class II |
| Mar 24, 2014 | Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Ma... | Chemical Contamination: Product were manufactured with active pharmaceutical ... | Class II |
| Mar 20, 2014 | Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Ap... | Failed Impurities/Degradation Specifications: Out of Specification for an imp... | Class III |
| Jul 17, 2013 | Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by A... | Presence of Particulate Matter: Product from lot KF2199, may contain tablets ... | Class II |
| Apr 30, 2012 | Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL... | Presence of Particulate Matter: Lots identified in this recall notification ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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