Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 cou... | 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 | CVS Allergy Relief, 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 | 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 | 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 |
| 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 | 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 | 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 | 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 | 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 | 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 26, 2021 | Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bott... | Marketed Without an Approved NDA/ANDA | Class II | High Performance Formulas, L.L.C. (HPF, L.L.C.) |
| Jul 23, 2021 | PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Profession... | SubPotent: Out of Specification | Class II | Professional Disposables International, Inc |
| Jul 23, 2021 | PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable Int... | SubPotent: Out of Specification | Class II | Professional Disposables International, Inc |
| Jul 23, 2021 | PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Pr... | SubPotent: Out of Specification | Class II | Professional Disposables International, Inc |
| Jul 23, 2021 | PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable In... | SubPotent: Out of Specification | Class II | Professional Disposables International, Inc |
| Jul 23, 2021 | PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable Inter... | SubPotent: Out of Specification | Class II | Professional Disposables International, Inc |
| Jul 23, 2021 | PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professiona... | SubPotent: Out of Specification | Class II | Professional Disposables International, Inc |
| Jul 23, 2021 | PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packag... | SubPotent: Out of Specification | Class II | Professional Disposables International, Inc |
| Jul 20, 2021 | Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : ... | Marketed without ANDA/NDA approval | Class II | HIS ENTERPRISE INC |
| Jul 19, 2021 | Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent P... | Correct Labeled Product Mispack | Class II | Teligent Pharma, Inc. |
| Jul 19, 2021 | Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Red... | Failed Tablet/Capsule Specification: Some tablets are shaved | Class II | Dr. Reddy's Laboratories, Inc. |
| Jul 19, 2021 | Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma... | Correct Labeled Product Mispack | Class II | Teligent Pharma, Inc. |
| Jul 15, 2021 | Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendsh... | cGMP Deviations | Class II | API Solutions Inc. |
| Jul 15, 2021 | Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne ... | cGMP Deviations | Class II | API Solutions Inc. |
| Jul 14, 2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzon... | cGMP Deviations | Class II | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (... | cGMP Deviations | Class II | Johnson & Johnson Consumer, 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.