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 Lidocaine HCl Jelly USP, 2%, 5mL tubes CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Midazolam Injection, USP 2mg/2mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Prednisolone Oral Solution, USP, 15 mg/5 mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Rifampin Capsules USP, 150 mg, 30-count bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Rifampin Capsules USP, 300 mg CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Fentanyl Citrate Injection, USP 100 mcg/2mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Timolol Maleate Ophthalmic Solution, USP 0.5% CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Calcitriol Injection 2 mcg/mL, 1 mL ampules CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Midazolam Injection, USP, 50 mg/10mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant… Product mix-up: incorrect product was found inside the G-Supress DX product carton. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 7, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJun 7, 2023ClassClass IStatusTerminatedWherePuerto Rico
- Medicine recall Microplegia (MSA/MSG 0.92 Molar) Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Warm Induction 4:1 High Potassium Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Reperfusate No Potassium Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Reperfusate No Potassium Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 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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