Medicines, 2025
Shortlist up to four to read them side by side.
765 medicine recalls FDA’s Enforcement Report published in 2025, 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.
765of 765 medicine recallsshown with your filters
The list
- Medicine recall Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76% CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76% CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76% CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76% CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76% CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76% CGMP Deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 28, 2025ClassClass IIStatusTerminatedWhereDelaware and North Carolina
- Medicine recall BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient… Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related… Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related… Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation Defective delivery system Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle cGMP deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle cGMP deviations Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne… Chemical Contamination: This recall has been initiated due to detected trace levels of benzene. Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit,… cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance… Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne… cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance… Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone Cypionate Injection, 200 mg/mL, CIII Lack of Assurance of Sterility Class IIFDA’s classMay 21, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL Presence of Particulate Matter FDA Class I, its most serious class Class IFDA’s class (needs attention)May 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants)… cGMP deviations and lack of assurance of sterility. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant… cGMP deviations and lack of assurance of sterility. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant,… cGMP deviations and lack of assurance of sterility. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye… cGMP deviations and lack of assurance of sterility. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ cGMP deviations and lack of assurance of sterility. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall FentaNYL 500mcg Lack of Assurance of Sterility Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportMissourithe one state its words name PublishedMay 14, 2025ClassClass IIStatusOngoingWhereMissouri
- Medicine recall temper tamer, 1 US fl oz. CGMP Deviations Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereFlorida, Pennsylvania and Virginia
- Medicine recall TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded… Presence of Particulate Matter: Glass particles were found in pellet vials. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded… Presence of Particulate Matter: Glass particles were found in pellet vials. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a… Presence of Particulate Matter: Glass particles were found in pellet vials. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded… Presence of Particulate Matter: Glass particles were found in pellet vials. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale,… Presence of Particulate Matter: Glass particles were found in pellet vials. Class IIFDA’s classMay 14, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Tirofiban Hydrochloride Injection 5 mg/100 mL Out-of-Specification test results were obtained in at long term conditions during 3 month’s stability study for related substances. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Tirofiban Hydrochloride Injection 12.5 mg/250 mL Out-of-Specification test results were obtained in at long term conditions during 3 month’s stability study for related substances. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles cGMP Deviations Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereCalifornia and Pennsylvania
- Medicine recall Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use… Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNorth Carolina, South Carolina and Virginia
- Medicine recall Levothyroxine Sodium Tablets, USP, 25 mcg Subpotent Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 50 mcg Subpotent Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 88 mcg Subpotent Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 112 mcg Subpotent Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass 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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