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.

Clear
DateProductReasonClassFirm
Dec 20, 2024 Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg... Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved dr... Class I ENDO USA, Inc.
Mar 27, 2024 NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottl... Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month... Class III Esperion
Mar 4, 2024 Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenou... Presence of Particulate Matter. Class I Par Sterile Products LLC
Jan 11, 2024 Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 u... Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper speci... Class II Par Sterile Products LLC
Aug 16, 2023 Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Man... Failed dissolution specifications: below specification results at stability 12-month Class III Esperion
Feb 9, 2023 aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Pac... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cart... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-co... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count ... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count c... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons,... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons,... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-c... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 9, 2023 allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-... Failed Impurities/Degradation Specifications Class II L. Perrigo Company
Feb 28, 2022 PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 ... Failed Dissolution Specifications Class II The Harvard Drug Group
Feb 24, 2022 hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister pa... Failed Impurities/Degradation Specifications: Out of specification result obtained during routine... Class II The Harvard Drug Group
Nov 9, 2021 Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use,... Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during ... Class II PAR Sterile Products LLC
Oct 26, 2021 Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) p... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with... 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 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 Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with... 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), two 4 ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ ... 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 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 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 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 No Drip Nasal Mist, Oxymetazoline HCl 0.05% Nasal decongestant, 1 FL Oz (30 m... 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 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 Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ ... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 26, 2021 Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1... 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 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 Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL O... 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 Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ ... 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 No Drip Nasal Decongestant, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bott... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... 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.