Medicines, 2022
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1,349 medicine recalls FDA’s Enforcement Report published in 2022, 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.
1,349of 1,349 medicine recallsshown with your filters
The list
- Medicine recall Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neostigmine methylsulfate, 5 mg/5mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection,… Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%,… Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl 0.5 mg/5mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl, 1mg/10mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per… Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose… Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution,… Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/… Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use… Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin HCl Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin HCl Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin HCl Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma,… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose Vials for… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg /… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma,… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, LLC, 856… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint,… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2%… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%,… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr.,… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Promethazine HCl Topical Ointment, 2.5% CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use… CGMP Deviations Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pioglitazone Tablets USP, 45 mg, 500 count bottles Superpotent and Failed Tablet/Capsule Specifications Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle Failed Dissolution Specifications Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol… cGMP deficiencies Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class IIIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class IIIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class IIIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class IIIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class IIIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIIStatusTerminatedWhereNationwide
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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