Browse Drug Recalls

104 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 104 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 104 FDA drug recalls.

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DateProductReasonClassFirm
Oct 26, 2021 No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... 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 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
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 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
Sep 16, 2020 Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhal... Defective Delivery System: Sustained trend of failure to dispense complaints. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per ... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [ND... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets pe... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per ... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per ... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Jan 18, 2016 Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perri... Labeling: label error on declared strength. 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.