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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.