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 Diclofenac Sodium Topical Solution 1.5%, 150 mL Defective Container: Leaking containers. Class IIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits. Class IIFDA’s classMar 30, 2022in FDA’s Enforcement ReportArkansasthe one state its words name PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereArkansas
- Medicine recall TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per… Lack of Assurance of Sterility Class IIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5%… Sub Potent Class IIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial,… Product found to be Sub Potent or Exceeded reconstitution time Class IIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10… Sub Potent Class IIIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 30, 2022ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL Super Potent Class IIIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 30, 2022ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL Sub Potent Class IIIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 30, 2022ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl… Sub Potent Class IIIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 30, 2022ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg,… Super Potent and Failed Reconstitution Time Class IIFDA’s classMar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 30, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 30, 2022ClassClass IStatusTerminatedWhereAlabama and Tennessee
- Medicine recall HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to… Class IIFDA’s classMar 30, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 30, 2022ClassClass IIStatusTerminatedWhereAlabama and Tennessee
- Medicine recall Sodium Acetate Injection, USP, 400 mEq / 100 mL Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprazolam Tablets, USP 1mg, 180-count bottles CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall 0.9% Sodium Chloride Injection USP, 250 mL Excel Container Lack of sterility assurance: leaking bags Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCl 2 mg/mL Infusion 250 mL bags Lack of Assurance of Sterility Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Hydromorphone HCl 1 mg/mL 250 mL bags Lack of Assurance of Sterility Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Hydromorphone HCl 5 mg/mL Infusion Lack of Assurance of Sterility Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Hydromorphone HCl 0.1 mg/mL Infusion Lack of Assurance of Sterility Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials Lack of Assurance of Sterility Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials Lack of Assurance of Sterility Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Vancomycin14 mg/mL Fortified Ophthalmic Solution Lack of Assurance of Sterility Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Morphine Sulfate 6 mg/mL Infusion Lack of Assurance of Sterility Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Ketamine 50 mg Infusion (LV 1) Solution Lack of Assurance of Sterility Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Lorazepam 1 mg/mL Infusion Solution Lack of Assurance of Sterility Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Methylcobalamin 1 mg/mL Injectable Lack of Assurance of Sterility Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Fentanyl 150 mcg/mL Infusion Solution Lack of Assurance of Sterility Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG* Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton Failed Dissolution Specifications Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprazolam C-IV 1 mg 60-count bottles CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.) Class IIFDA’s classMar 16, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 16, 2022ClassClass IIStatusTerminatedWhereFlorida, Georgia and Louisiana
- Medicine recall Alprazolam C-IV 2 mg, 60-count bottles CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.) Class IIFDA’s classMar 16, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 16, 2022ClassClass IIStatusTerminatedWhereFlorida, Georgia and Louisiana
- Medicine recall Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups Impurity failure at 0-time of the repackaged lot. Class IIFDA’s classMar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles cGMP deviations Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL Labeling - product contains undeclared ethyl alcohol Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Luxury 70% Isopropyl Alcohol, 16 FL Labeling - product contains undeclared ethyl alcohol Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL Failed impurities/degradation specifications Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Olanzapine Tablets, USP 10 mg, 30-count bottles cGmp Deviations Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall All Over-The-Counter (OTC) drug products CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 9, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Louisiana, Missouri, Mississippi and Tennessee
- Medicine recall Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle CGMP deviations Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HEB 50% Isopropyl Alcohol First Aid Antiseptic Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product. Class IIFDA’s classMar 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Norepinephrine bitartrate 16 mg Subpotent drug Class IIIFDA’s classMar 2, 2022in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 2, 2022ClassClass IIIStatusTerminatedWhereFlorida
- Medicine recall Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet… Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans cGMP deviations Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportColoradothe one state its words name PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereColorado
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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