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 Levothyroxine Sodium Tablets, USP, 50 mcg Subpotent Drug: Assay below the approved specification Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 100 mcg Subpotent Drug: Assay below the approved specification Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 112 mcg Subpotent Drug: Assay below the approved specification Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 150 mcg Subpotent Drug: Assay below the approved specification Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 175 mcg Subpotent Drug: Assay below the approved specification Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 23, 2025ClassClass IIStatusOngoingWhereCalifornia
- Medicine recall Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg… Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Rizatriptan Benzoate Tablets, USP, 5 mg, 18 CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rizatriptan Benzoate Tablets, USP, 10 mg, 18 CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P… CGMP Deviations Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant… CGMP Deviations Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8… CGMP Deviations Class IIFDA’s classJul 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Famciclovir Tablets, USP 500 mg, 30-count bottles Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle. Class IIIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class IIFDA’s classJul 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral… cGMP deviations Class IIFDA’s classJul 16, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 16, 2025ClassClass IIStatusOngoingWhereFlorida, Michigan and New Jersey
- Medicine recall Erin’s Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per… cGMP deviations Class IIFDA’s classJul 16, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 16, 2025ClassClass IIStatusOngoingWhereFlorida, Michigan and New Jersey
- Medicine recall GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients,… cGMP deviations Class IIFDA’s classJul 16, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 16, 2025ClassClass IIStatusOngoingWhereFlorida, Michigan and New Jersey
- Medicine recall In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free,… cGMP deviations Class IIFDA’s classJul 16, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 16, 2025ClassClass IIStatusOngoingWhereFlorida, Michigan and New Jersey
- Medicine recall LIDOcaine HCl Injection, USP, 10mg/mL, 1% Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5% Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall KETAmine Hydrochloride Injection, USP, 50 mg/5mL Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall KETAmine Hydrochloride Injection, USP, 500mg/5mL Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1% Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2% Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Gabapentin Capsules, USP, 100 mg, 100 capsules Defective container; blister packaging inadequately sealed. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Gabapentin Capsules, USP, 100 mg, 10 capsules Defective container; blister packaging inadequately sealed. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pitavastatin Tablets, 2 mg Failed Impurities/Degradation Specifications. Class IIIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedJul 9, 2025ClassClass IIIStatusOngoingWhereNew Jersey
- Medicine recall Pitavastatin Tablets, 1 mg Failed Impurities/Degradation Specifications. Class IIIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedJul 9, 2025ClassClass IIIStatusOngoingWhereNew Jersey
- Medicine recall Pitavastatin Tablets, 1 mg, 90 Tablets per bottle Failed Impurity/Degradation Specifications Class IIIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Pitavastatin Tablets, 2 mg, 90 Tablets per bottle Failed Impurity/Degradation Specifications Class IIIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Metoclopramide Tablets, USP 10 mg, 100-count bottle Presence of foreign tablets/capsules. Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite… Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204,… Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and… Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl… Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88… Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204,… Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204,… Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness,… Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite… Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite… Lack of Assurance of Sterility Class IIFDA’s classJul 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 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.
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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