Browse Drug Recalls

448 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 448 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 448 FDA drug recalls in MI.

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DateProductReasonClassFirm
Oct 26, 2021 Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (5... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Deconges... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL O... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
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
Oct 26, 2021 Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 0.05% Na... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongest... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Severe Congestion No Drip Nasal Spray Plus Menthol, Oxymetazoline HCl 0.05%, ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongest... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (5... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongest... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%,... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL O... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
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
Aug 6, 2021 Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx onl... Failed Dissolution Specifications Class II The Harvard Drug Group
Aug 3, 2021 Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distribute... Failed Impurities/Degradation Specifications Class II The Harvard Drug Group
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 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

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.