Apotex recalls
Apotex appears in 76 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-07.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 76 |
|---|---|
| Published | 2012-08-08 to 2026-10-07 |
| By agency | FDA Drug (76) |
| By classification | Class II (53), Class III (17), Class I (6) |
| By status | terminated (48), ongoing (18), completed (10) |
| Distribution named in notices | IL, MS, NJ, OH, TX, US |
Recalls
- Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manu…
FDA Drug · Class II · 2026-10-07 · Apotex
Reason: Failed dissolution specifications. - Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9…
FDA Drug · Class II · 2026-09-02 · Apotex
Reason: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria - Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg…
FDA Drug · Class II · 2026-04-22 · Apotex
Reason: Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners. - Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp
FDA Drug · Class II · 2026-03-25 · Apotex
Reason: Lack of Assurance of Sterility - Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C…
FDA Drug · Class II · 2025-10-08 · Apotex
Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns - Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc.,…
FDA Drug · Class II · 2025-10-08 · Apotex
Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns - Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufact…
FDA Drug · Class II · 2025-07-02 · Apotex
Reason: Lack of Assurance of Sterility - Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontari…
FDA Drug · Class II · 2025-07-02 · Apotex
Reason: Lack of Assurance of Sterility - Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for:…
FDA Drug · Class II · 2025-07-02 · Apotex
Reason: Lack of Assurance of Sterility - Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for:…
FDA Drug · Class II · 2025-06-11 · Apotex
Reason: Defective Container: This recall is being initiated due to a leaking unit stored horizontally. - Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc
FDA Drug · Class II · 2024-02-28 · Apotex
Reason: CGMP Deviations: potential presence of Burkholderia cepacia complex - Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1
FDA Drug · Class II · 2023-12-06 · Apotex
Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine - Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-…
FDA Drug · Class II · 2023-12-06 · Apotex
Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine - Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2
FDA Drug · Class II · 2023-12-06 · Apotex
Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine - Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario,…
FDA Drug · Class II · 2023-12-06 · Apotex
Reason: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine - Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle…
FDA Drug · Class II · 2023-05-17 · Apotex
Reason: Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable. - Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5
FDA Drug · Class II · 2023-03-15 · Apotex
Reason: Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility. - Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc
FDA Drug · Class III · 2023-01-04 · Apotex
Reason: Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life. - Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2…
FDA Drug · Class II · 2022-07-27 · Apotex
Reason: Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. - Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc
FDA Drug · Class III · 2022-05-25 · Apotex
Reason: Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint. - Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc
FDA Drug · Class II · 2021-04-14 · Apotex
Reason: Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate - Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL Si…
FDA Drug · Class I · 2021-02-17 · Apotex
Reason: Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength) - Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Do…
FDA Drug · Class I · 2021-02-17 · Apotex
Reason: Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) - Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8
FDA Drug · Class II · 2020-11-25 · Apotex
Reason: Failed Dissolution Specifications: Out of specification for dissolution. - Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc
FDA Drug · Class II · 2020-06-24 · Apotex
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels - Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed B…
FDA Drug · Class II · 2019-11-20 · Apotex
Reason: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). - Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4 Distributed…
FDA Drug · Class II · 2019-11-20 · Apotex
Reason: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). - Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011…
FDA Drug · Class II · 2019-11-20 · Apotex
Reason: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). - Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield,…
FDA Drug · Class II · 2019-11-20 · Apotex
Reason: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). - Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed By: Walgreen Co.,…
FDA Drug · Class II · 2019-11-20 · Apotex
Reason: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). - Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc
FDA Drug · Class II · 2019-11-20 · Apotex
Reason: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). - Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc
FDA Drug · Class III · 2019-11-06 · Apotex
Reason: Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg. - 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…
FDA Drug · Class II · 2019-03-13 · Apotex
Reason: Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. - Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Ma…
FDA Drug · Class II · 2018-06-13 · Apotex
Reason: Presence of foreign substance: glass particles - Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare In…
FDA Drug · Class I · 2018-05-23 · Apotex
Reason: Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency - Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare…
FDA Drug · Class I · 2018-05-23 · Apotex
Reason: Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency - CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apot…
FDA Drug · Class II · 2017-03-01 · Apotex
Reason: Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities. - Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9
FDA Drug · Class III · 2017-02-15 · Apotex
Reason: Superpotent Drug: Product may not meet specifications throughout shelf life. - Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apo…
FDA Drug · Class II · 2017-01-11 · Apotex
Reason: CGMP Deviations - Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apot…
FDA Drug · Class II · 2017-01-11 · Apotex
Reason: CGMP Deviations - 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 f…
FDA Drug · Class II · 2015-10-21 · Apotex
Reason: Lack of Assurance of Sterility: Failed preservative effectiveness testing - Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp
FDA Drug · Class III · 2015-10-07 · Apotex
Reason: Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits. - Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd.…
FDA Drug · Class II · 2015-09-23 · Apotex
Reason: Failed Stability Specifications: product may not meet specification limit for assay test. - Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Researc…
FDA Drug · Class II · 2015-07-15 · Apotex
Reason: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. - Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Researc…
FDA Drug · Class II · 2015-07-15 · Apotex
Reason: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. - Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, O…
FDA Drug · Class II · 2015-07-15 · Apotex
Reason: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. - Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research…
FDA Drug · Class II · 2015-07-15 · Apotex
Reason: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. - Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc
FDA Drug · Class III · 2015-05-20 · Apotex
Reason: Subpotent drug - Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only,…
FDA Drug · Class III · 2015-05-20 · Apotex
Reason: Subpotent drug - Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only…
FDA Drug · Class III · 2015-05-20 · Apotex
Reason: Subpotent drug