Browse Drug Recalls
62 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 62 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 62 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 5, 2025 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Man... | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to po... | Class II | Apotex Corp. |
| Sep 5, 2025 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL ... | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to po... | Class II | Apotex Corp. |
| May 28, 2025 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, R... | Lack of Assurance of Sterility | Class II | Apotex Corp. |
| May 28, 2025 | Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Ap... | Defective Container: This recall is being initiated due to a leaking unit stored horizontally. | Class II | Apotex Corp. |
| May 28, 2025 | Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. ... | Lack of Assurance of Sterility | Class II | Apotex Corp. |
| May 28, 2025 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufacture... | Lack of Assurance of Sterility | Class II | Apotex Corp. |
| Feb 9, 2024 | Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net ... | CGMP Deviations: potential presence of Burkholderia cepacia complex | Class II | Apotex Corp. |
| Nov 1, 2023 | Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#... | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... | Class II | Apotex Corp. |
| Nov 1, 2023 | Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, ND... | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... | Class II | Apotex Corp. |
| Nov 1, 2023 | Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, ND... | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... | Class II | Apotex Corp. |
| Nov 1, 2023 | Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#... | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... | Class II | Apotex Corp. |
| Apr 26, 2023 | Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon ... | Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat render... | Class II | Apotex Corp. |
| Mar 1, 2023 | Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL... | Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartr... | Class II | Apotex Corp. |
| Dec 21, 2022 | Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apote... | Failed Stability Specifications: Out of specification for weight loss at the 18-month stability t... | Class III | Apotex Corp. |
| Jul 7, 2022 | Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 6050... | Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. | Class II | Apotex Corp. |
| May 3, 2022 | Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apo... | Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded th... | Class III | Apotex Corp. |
| Mar 31, 2021 | Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufact... | Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiap... | Class II | Apotex Corp. |
| Mar 15, 2021 | Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Appl... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Feb 2, 2021 | Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Aut... | Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 m... | Class I | Apotex Corp. |
| Feb 2, 2021 | Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automati... | Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 12... | Class I | Apotex Corp. |
| Nov 11, 2020 | Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, ND... | Failed Dissolution Specifications: Out of specification for dissolution. | Class II | Apotex Corp. |
| Jun 12, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (1... | CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established... | Class II | The Harvard Drug Group |
| May 27, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottl... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable in... | Class II | Apotex Inc. |
| 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 found in bottle of Ato... | Class III | Apotex Inc. |
| 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 | Apotex Inc. |
| May 31, 2018 | Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray... | Presence of foreign substance: glass particles | Class II | Apotex Inc. |
| 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 | Apotex Inc. |
| 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 | Apotex Inc. |
| Feb 3, 2017 | CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by... | Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown I... | Class II | Apotex Inc. |
| 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 | Apotex Inc. |
| Dec 14, 2016 | Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex I... | CGMP Deviations | Class II | Apotex Corp. |
| Dec 14, 2016 | Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex In... | CGMP Deviations | Class II | Apotex Corp. |
| Jan 26, 2016 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, M... | Failed Dissolution Specification: Out of specification dissolution results when testing product s... | Class III | Apotex Scientific, Inc |
| Jan 26, 2016 | Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, M... | Failed Dissolution Specification: Out of specification dissolution results when testing product s... | Class III | Apotex Scientific, Inc |
| Jan 26, 2016 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, M... | Failed Dissolution Specification: Out of specification dissolution results when testing product s... | Class III | Apotex Scientific, Inc |
| 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 | Apotex Inc. |
| 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 stage dissolution spe... | Class III | Apotex Inc. |
| 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 | Apotex Inc. |
| Oct 16, 2014 | Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured b... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... | Class III | Apotex Inc. |
| 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) results were observed fo... | Class III | Apotex Inc. |
| 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) results were observed fo... | Class III | Apotex Inc. |
| Oct 16, 2014 | Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured b... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed fo... | Class III | Apotex Inc. |
| Aug 21, 2014 | Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count... | Failed Impurity/Degradation Specification; high out of specification for CAD II degradant | Class III | Apotex Corp. |
| Apr 18, 2014 | Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manu... | Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point. | Class III | Apotex Corp. |
| Mar 24, 2014 | Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, ... | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... | Class II | Apotex Inc. |
| Mar 24, 2014 | PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured ... | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... | Class II | Apotex Inc. |
| 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 ingredient (API) bat... | Class II | Apotex Inc. |
| Mar 24, 2014 | PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, ... | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... | Class II | Apotex Inc. |
| Mar 24, 2014 | Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, ... | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... | Class II | Apotex Inc. |
| Mar 24, 2014 | PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle... | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) bat... | Class II | Apotex Inc. |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.