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 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 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
- Medicine recall Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 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 Sodium Chloride Ophthalmic Ointment, USP, 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 Timolol Maleate Ophthalmic Solution, USP, 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 Tobramycin Ophthalmic Solution, USP, 0.3%, 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 Tobramycin 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 Rasagiline Mesylate Tablets 1 mg Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets. Class IIFDA’s classJan 25, 2023in FDA’s Enforcement Report20 statesnamed in where it went PublishedJan 25, 2023ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Washington and Wisconsin
- Medicine recall Triamterene and Hydrochlorothiazide Capsules, USP Failed Impurity/Degradation Specifications Class IIIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Triamterene and Hydrochlorothiazide Capsules, USP Failed Impurity/Degradation Specifications Class IIIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Levofloxacin Tablets, USP 500 mg Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles. Class IIIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 25, 2023ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product,… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product,… Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rifampin Capsules USP, 300 mg, 100 Capsules Failed Impurities/Degradations Specifications Class IIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SIREtizer Hand Sanitizer (Ethyl Alcohol) 80% CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Class IIFDA’s classJan 25, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 25, 2023ClassClass IIStatusOngoingWhereIowa and Nebraska
- Medicine recall SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months. Class IIIFDA’s classJan 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Rifampin Capsules, 300 mg, 30 count blister card Failed Impurities/Degradation specifications Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJan 18, 2023ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Rocuronium Bromide Injection, 50 mg/5 mL Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rifampin Capsules USP, 300 mg, 30-count bottle Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL cGMP deviation: discontinue of stability support for product. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportFloridathe one state its words name PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Mitomycin Injection Solution, 4mg/ml Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prostaglandin (E1) Injection Solution, 10 mcg/ml Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL… Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL… Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL… Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL… Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL… Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin Injection Solution, 12.5mg/ml Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE,… Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE Lack of Assurance of Sterility Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acyclovir Sodium Injection 1,000 mg per 20 mL* Presence of Particulate Matter: Customer complaint of dark particles found inside the vial Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets Subpotent Drug: Out of specification for assay at the 18-month stability timepoint. Class IIIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Heparin Sodium 2,000, USP Units, per 1,000 mL Lack of assurance of sterility: Bags have the potential to leak. Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial,… CGMP Deviations: Raw material recalled by repackager, due to discoloration. Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 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.”
Your shortlist0 of 4
Add one more to compare.