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 Entecavir Tablets, USP, 0.5 mg, 30-count bottle Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Entecavir Tablets, USP, 1 mg, 30-count bottle Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton Failed Dissolution Specifications. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320… cGMP Deviations Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Kroger 70% Isopropyl Alcohol Cross Contamination with Other Products. Class IIIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall TopCare Health 70% Isopropyl Alcohol Cross Contamination with Other Products. Class IIIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only CGMP Deviations: Market complaints received for gritty texture (grainy) Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl… Class IIFDA’s classOct 1, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereCalifornia and Georgia
- Medicine recall Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl… Class IIFDA’s classOct 1, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereCalifornia and Georgia
- Medicine recall Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl… Class IIFDA’s classOct 1, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereCalifornia and Georgia
- Medicine recall mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210 Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl… Class IIFDA’s classOct 1, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereCalifornia and Georgia
- Medicine recall Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl… Class IIFDA’s classOct 1, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereCalifornia and Georgia
- Medicine recall edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl… Class IIFDA’s classOct 1, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereCalifornia and Georgia
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine… Failed Impurities/Degradation Specifications: Class IIIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine… Failed Impurities/Degradation Specifications: Class IIIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine… Failed Impurities/Degradation Specifications: Class IIIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine… Failed Impurities/Degradation Specifications: Class IIIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine… Failed Impurities/Degradation Specifications: Class IIIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon Subpotent drug Class IIIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Aripiprazole Tablets, USP, 10 mg, 30-count bottles Superpotent drug Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall bevacizumab (Avastin) Injection, 1.25mg/0.05mL Lack of Assurance of Sterility Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall chlorproMAZINE Hydrochloride Tablets, USP, 25 mg Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cyclophosphamide Injection 500 mg/5 mL cGMP deviations: Temperature excursion during transportation. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall STERILE WATER FOR INJECTION USP, 3000mL Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 0.9% SODIUM CHLORIDE IRRIGATION USP Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 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 by manufacturer (Amneal Pharmaceuticals LLC) was… Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Entecavir Tablets, USP, 0.5 mg, 30 Tablets Failed Impurity/Degradation Specifications Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Entecavir Tablets, USP, 1 mg, 30 Tablets Failed Impurity/Degradation Specifications Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Kit for the Preparation of Technetium Tc 99m Mertiatide Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide. Class IIFDA’s classSep 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereArizona, Indiana and New Jersey
- Medicine recall Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl Defective Container: broken or leaking bottles. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportFloridathe one state its words name PublishedSep 17, 2025ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Succinylcholine Chloride Injection, USP 200 mg/10 mL Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity. Class IIFDA’s classSep 17, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereLouisiana, Mississippi, Ohio and Puerto Rico
- Medicine recall Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was… Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was… Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Temperature Abuse Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedSep 17, 2025ClassClass IIStatusOngoingWhereCalifornia
- Medicine recall Neuroquell & Neuroquell Plus, .22 fl cGMP violations Class IIFDA’s classSep 17, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 17, 2025ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Chlorpromazine Hydrochloride Tablets, USP, 10 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, 10 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, 25 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, 25 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, 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
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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