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Browse Drug Recalls

305 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 305 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 305 FDA drug recalls.

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DateProductReasonClassFirm
Jan 18, 2022 Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 ... Failed Dissolution Specification: Dissolution results are below specification limits for the acti... Class II Teva Pharmaceuticals USA
Jan 10, 2022 Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals US... Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution. Class II Teva Pharmaceuticals USA
Jan 7, 2022 Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packag... Mislabeling Class III Teva Pharmaceuticals USA
Jan 7, 2022 Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, package... Mislabeling Class III Teva Pharmaceuticals USA
Dec 31, 2021 Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Dec 31, 2021 MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 1... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Dec 16, 2021 Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) ... Subpotent Class II Teva Pharmaceuticals USA
Dec 8, 2021 Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottl... Defective Container: The notch in the cap that fits into the nozzle of the dropper could break of... Class II Teva Pharmaceuticals USA
Oct 28, 2021 Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, ... Failed Impurities/Degradation Specifications Class III Teva Pharmaceuticals USA
Oct 27, 2021 Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx... Labelling: Incorrect Exp. Date Class II Teva Pharmaceuticals USA
Sep 22, 2021 AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg... Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class II Teva Pharmaceuticals USA
Sep 22, 2021 AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg... Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class II Teva Pharmaceuticals USA
Sep 22, 2021 AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg... Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class II Teva Pharmaceuticals USA
Sep 22, 2021 AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg... Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class II Teva Pharmaceuticals USA
Sep 22, 2021 AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) ... Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class II Teva Pharmaceuticals USA
Jul 29, 2021 Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx onl... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceutic... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx on... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single us... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials,... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx on... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) ... Class II Teva Pharmaceuticals USA
Jul 29, 2021 Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vi... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx on... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Tev... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) ... Class II Teva Pharmaceuticals USA
Jul 29, 2021 Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) ... Class II Teva Pharmaceuticals USA
Jul 29, 2021 Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, p... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Ph... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jun 18, 2021 Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceutical... Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. ... Class I Teva Pharmaceuticals USA
Apr 26, 2021 Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multipl... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx On... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Onl... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Mar 15, 2021 EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (A... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister C... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by:... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 4, 2021 Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Phar... Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities... Class III Teva Pharmaceuticals USA

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.