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 5, 2026.
765of 765 medicine recallsshown with your filters
The list
- Medicine recall Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide… Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate… Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine… Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportOhiothe one state its words name PublishedSep 17, 2025ClassClass IIStatusCompletedWhereOhio
- Medicine recall chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets Presence of a foreign substance. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets Presence of a foreign substance. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy Subpotent Drug Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496 Subpotent Drug Class IIIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy Subpotent Drug Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy Subpotent Drug Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%) Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does… Subpotent Drug Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lactated Ringers’s Injection USP, 1000 mL container Presence of Particulate Matter FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP, 1000 mL container Presence of Particulate Matter. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Acetaminophen Injection 1000 mg/100 mL Discoloration Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportKansasthe one state its words name PublishedSep 3, 2025ClassClass IIStatusOngoingWhereKansas
- Medicine recall Sucralfate Tablets, USP 1 gram, 100 Tablets CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles Labeling: Label Mix-up. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large,… Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use… Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Good Neighbor Pharmacy, Alcohol Prep Pads Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall RITE AID PHARMACY, first aid alcohol prep pads Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100… Lack of Assurance of Sterility. Class IIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 27, 2025ClassClass IIStatusOngoingWhereNew York
- Medicine recall Vial Label: Epinephrine Injection, USP, 1mg/10mL Lack of Assurance of Sterility. Class IIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL Lack of Assurance of Sterility. Class IIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive… Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. Class IIIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month… Class IIIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Carvedilol Tablets USP, 12.5 mg, 100- Tablets CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm Class IIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Tavaborole Topical Solution 5%, 10 mL per glass bottle Discoloration Class IIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle Subpotent drug Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle Failed Dissolution Specifications: low dissolution results Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carvedilol Tablets, USP, 3.125 mg CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carvedilol Tablets, USP, 12.5 mg, 500-count bottle CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carvedilol Tablets, USP, 25 mg, 500-count bottle CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 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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