Medicines, 2023
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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 METHOTREXATE 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 METHYLCOBALAMIN 12.5MG/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 MITOMYCIN 0.2MG/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 MITOMYCIN 0.4MG/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 NADH 10MG/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 PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/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 PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/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 PE1/PAPAV/PHEN 20MCG/30MG/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 PHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. 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 PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID 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 POLIDOCANOL 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 POLYHEXAMETHYLENE BIGUANIDE 0.2MG/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 PROGESTERONE-GS OIL- 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 PROSTAGLANDIN (PE1) 45MCG 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 SCOPOLAMINE HYDROBROMIDE 0.25% 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 SEMAGLUTIDE 0.5MG/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 TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 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 TESTOSTERONE 3% 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 THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/25MG/20MG/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 TOBRAMYCIN FORTIFIED 15MG/ML 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 VANCOMYCIN FORTIFIED 10MG/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 VITAMIN D3-AQUEOUS- 10,000IU/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 VORICONAZOLE 10MG/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 Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate),… Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate),… Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate),… Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daptomycin for Injection 350 mg/vial 1 Single-dose vial Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Artificial Tears OINTMENT, Lubricant Eye Ointment CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall GONAK Hypromellose Ophthalmic Demulcent Solution CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ketorolac Tromethamine Ophthalmic Solution, 0.5% CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lidocaine Hydrochloride Jelly USP, 2% CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle CGMP Deviations: Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
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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