Medicines, 2022
Shortlist up to four to read them side by side.
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 5, 2026.
1,349of 1,349 medicine recallsshown with your filters
The list
- Medicine recall Oxcarbazepine Tablets 600mg Presence of foreign substance Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycopyrrolate Tablets, USP, 1 mg, 100 tablets Failed Impurities/Degradation Specifications Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Quinapril Tablets USP, 40 mg CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Quinapril Tablets USP, 20 mg CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FentaNYL Citrate 2.5 mg/50 mL Underfilled units. Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportMissourithe one state its words name PublishedDec 21, 2022ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil cGMP Deviations Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neuroquell, A Homeopathic Drug, Calendula Oil cGMP Deviations Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ProSirona, A Homeopathic Formula, Calendula Oil cGMP Deviations Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Menastil, A Homeopathic Formula, Calendula Oil cGMP Deviations Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged… Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement ReportFloridathe one state its words name PublishedDec 21, 2022ClassClass IStatusTerminatedWhereFlorida
- Medicine recall Lacosamide Oral Solution, USP, CV, 10mg/mL Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content Class IIIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR… Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Lack of sterility assurance: Bags have the potential to leak. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 14, 2022ClassClass IIStatusTerminatedWhereFlorida, New Jersey and Pennsylvania
- Medicine recall Desmopressin Acetate Tablet, 0.2 mg, 100-count box Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportMichiganthe one state its words name PublishedDec 14, 2022ClassClass IIStatusTerminatedWhereMichigan
- Medicine recall Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours Defective Delivery System: Recalled lot was found to be out of specification for shear. Class IIFDA’s classDec 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Desmopressin Acetate Tablets 0.2mg, 100-count bottles Subpotent Drug Class IIFDA’s classDec 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant,… Failed dissolution specifications Class IIIFDA’s classDec 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period. Class IIIFDA’s classDec 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only… Discoloration Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenytoin Sodium Injection, USP 100 mg/2 mL Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. Class IIIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Phenytoin Sodium Injection, USP, 250 mg/5 mL Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. Class IIIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial Failed Stability Specifications Class IIIFDA’s classNov 23, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 23, 2022ClassClass IIIStatusTerminatedWhereAlabama, Kentucky, Pennsylvania and Tennessee
- Medicine recall Timolol-Latanoprost Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles Failed Impurities/Degradation Specifications Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carvedilol Tablets, USP, 25 mg, 500-count bottles Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PF-Labetalol HCl Injection, USP 20 mg/4 mL CGMP Deviations: Potential for cross contamination due to product carry over. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL CGMP Deviations: Potential for cross contamination due to product carry over. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Adam’s Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v Chemical Contamination: FDA analysis found 1 lot of Adam’s Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2022ClassClass IStatusOngoingWhereNationwide
- Medicine recall Adam’s Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain… Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or… Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles Presence of Foreign Substance Class IIFDA’s classNov 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Susvimo (ranibizumab injection), 100mg/mL Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the… Class IIIFDA’s classNov 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 9, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall BRILLIANT BLUE G, 0.04% Solution, 2 mL vials Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall CYCLOSPORIN 0.07% OPTH 0.07% Solution Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall LAURETH-9 INJ 2% Solution, 30 ML vial Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products… Class IIFDA’s classNov 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 9, 2022ClassClass IIStatusOngoingWhereAlabama, Louisiana, Mississippi and Tennessee
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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