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 ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100… Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 5, 2025ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Avastin 1.25 mg/0.05 mL Lack of Assurance of Sterility: due to a quality control process deviation Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate In Sodium Chloride 1600mcg/100mL Lack of Assurance of Sterility Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedFeb 26, 2025ClassClass IIStatusCompletedWherePennsylvania
- Medicine recall Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Silodosin Capsules, 8mg, 90-count bottle Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT… Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Phenylephrine HCl Injection, USP 100 mg/10 mL Presence of Particulate Matter. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class IIFDA’s classFeb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Fentanyl Transdermal System CII, 25mcg/h Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Irbesartan Tablets USP, 300 mg, 50 Tablets Out of Specification for Dissolution Class IIFDA’s classFeb 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL 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 classFeb 12, 2025in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNew Jersey
- Medicine recall Carvedilol Tablets, USP, 25 mg CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carvedilol Tablets, USP, 12.5 mg CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportFloridathe one state its words name PublishedFeb 12, 2025ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets Failed Impurities/Degradation Specifications Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall HydrALAZINE Hydrochloride, 100 Tablets Failed Impurities/Degradation Specifications Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Potassium Chloride Extended-Release Tablets, USP, 10 mEq Failed Dissolution Specifications. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz Superpotent; sodium benzoate preservative Class IIIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportOhiothe one state its words name PublishedFeb 12, 2025ClassClass IIIStatusTerminatedWhereOhio
- Medicine recall Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP) FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use. Class IIIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules USP, 20 mg CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Inflectra (infliximab-dyyb), For injection, 100mg per vial cGMP Deviations: Product intended for quarantine was inadvertently distributed. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Kissable Diabetics Foot Cream CGMP Deviations: lack of adequate release testing. Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla CGMP Deviations; product intended for quarantine was inadvertently distributed Class IIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Venlafaxine Extended-Release Tablets, 150mg Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet Class IIIFDA’s classJan 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2025ClassClass IIIStatusCompletedWhereNationwide
- Medicine recall Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E,… Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class IIIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building… Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class IIIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class IIIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class IIIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class IIIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIIStatusOngoingWhereNationwide
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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