Medicines, 2023
Shortlist up to four to read them side by side.
1,252 medicine recalls FDA’s Enforcement Report published in 2023, newest first; 18,075 in all since 2012.
FDA’s medicine recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
1,252of 1,252 medicine recallsshown with your filters
The list
- Medicine recall Allopurinol Tablets 100mg, USP, 90-count bottles Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards… Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportIndianathe one state its words name PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereIndiana
- Medicine recall Clobetasol propionate Cream USP, 0.05%, 45 g tube Subpotent Drug: Low assay result observed during long-term stability testing. Class IIIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile… Short Fill Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a… Short Fill Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag CGMP Deviations: potential for trace amounts of product carryover. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial CGMP Deviations: potential for trace amounts of product carryover. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 1, 2023ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Epinephrine (L-Adrenaline), USP, CAS 51-43-4 Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 1, 2023ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Advil (ibuprofen) Tablets, 200 mg Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid… Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200… Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials… Presence of Particulate Matter: Glass particulate matter detected in injectable. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 1, 2023ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dutasteride 0.1% Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Chlorpheniramine/Hyoscyamine Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydroxocobalamin 25MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin 1MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Minoxidil 0.75% Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetylcysteine 10% Ophthalmic Solution Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Apomorphine HCL 2MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BSS Plus/Lidocaine Opth 1% Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Buprenorphine HCL 0.9 MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ceftazidime Intravitreal Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cholecalciferol (Vitamin D3) 100,000U/ML Injectable Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclosporine (A) 0.1% Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DEXAMETHASONE 16MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Edetate Calcium Disodium 400MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EDETATE DISODIUM (VET) 1% Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 0.05% OPH Solution Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ethyl Alcohol 95% Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FLURBIPROFEN -CORN OIL- 0.04% Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GENTAMICIN BLADDER 0.08MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GLUTATHIONE L REDUCED 100MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GLYCERIN 72% (W/V) Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROXOCOBALAMIN-PF- 1MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall KETAMINE 50MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LEVEMIR-STS- 100U/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LIDOCAINE-PF- 5% Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MAGNESIUM CHLORIDE HEXAHYDRATE-PF- 200MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class IIFDA’s classFeb 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2023ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Drug recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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