Medicines, 2024
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657 medicine recalls FDA’s Enforcement Report published in 2024, 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.
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The list
- Medicine recall Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton Superpotent Drug: The 3-month stability result for assay was found to be above specification limit Class IIFDA’s classApr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Methocarbamol Injection, USP 1000mg/10mL Presence of Particulate Matter FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lactated Ringer’s Injection USP, 1000mL, EXCEL CONTAINER Lack of assurance of sterility: bags have the potential to leak.. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services,… Lack of Assurance of Sterility: leaking bags Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for… Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. Class IIIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution,… Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. Class IIIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous Lack of Assurance of Sterility: Firm did not perform process validation. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportMissourithe one state its words name PublishedApr 10, 2024ClassClass IIStatusOngoingWhereMissouri
- Medicine recall FentaNYL citrate, 10 mcg Lack of Assurance of Sterility: Firm did not perform process validation. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportMissourithe one state its words name PublishedApr 10, 2024ClassClass IIStatusOngoingWhereMissouri
- Medicine recall Diltiazem HCl 125 mg Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2,500 mcg/250 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2,500 mcg/50 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl 20 mg/100mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl 6 mg/30 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl 6 mg/30 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl 10 mg/50 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl 25 mg/25 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl 30 mg/30mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl 30 mg/30 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam HCl 100 mg/100 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 1000 mcg/10 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 500 mcg/5 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 500 mcg/5 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 5000 mcg/50 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 400 mcg/10 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 40 mg Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 800 mcg/10 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 800 mcg/10 mL Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe,… Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag Lack of Assurance of Sterility Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Divalproex Sodium Extended-release Tablets, USP 250 mg Failed dissolution specifications Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films cGMP Diviations Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen Failed Dissolution Specifications Class IIFDA’s classApr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Treprostinil Injection, 20 mg/20 mL Presence of Particulate Matter. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Digoxin Tablets, USP 125mcg Cross Contamination with Other Products:(mycophenolate mofetil). Class IIIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nicardipine Hydrochloride Injection Failed Impurities/Degradation Specifications: Out of specification for organic impurities Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nicardipine Hydrochloride Injection, USP 25mg/mL Failed Impurities/Degradation Specifications: Out of specification for organic impurities Class IIFDA’s classMar 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 27, 2024ClassClass 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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