Browse Drug Recalls
1,152 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,152 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 1,152 FDA drug recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with F... | Failed Stability Specification; Out of specification for Osmolarity | Class II | Novel Laboratories, Inc. d.b.a LUPIN |
| 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 | Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY... | Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. | Class II | PAI Holdings, LLC. dba Pharmaceutical Associate... |
| Jul 29, 2021 | Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, D... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| 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 | Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a lam... | Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determi... | Class III | Teligent Pharma, Inc. |
| Jul 29, 2021 | Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx L... | Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| 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 | Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Phar... | Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. | Class II | PAI Holdings, LLC. dba Pharmaceutical Associate... |
| 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 |
| Jul 27, 2021 | MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 coun... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine,... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg An... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 c... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | GoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets, 30 co... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine,... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antih... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | allergyrelief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine ... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamin... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Wal-Fex Fexofenadine Hydrochloride tablets, 180mg/antihistamine, 24HR, pack... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | amazon, Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 2... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistam... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihis... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihist... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packag... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | up&up allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/antihis... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antih... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine ... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 c... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, ... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihi... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine,... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihist... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihis... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihi... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 co... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Meijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antih... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
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.