Medicines, 2024
Shortlist up to four to read them side by side.
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 5, 2026.
657of 657 medicine recallsshown with your filters
The list
- Medicine recall Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL Presence of Particulate Matter: Potential for glass delamination from the vials. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall VitalityXtra Capsules, 500 mg Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall PeakMax Capsules, 500 mg Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall ZoomMax Capsules, 500 mg, 10 count blisters in cartons Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall ZapMax Capsules, 500 mg, 10 count blisters in cartons Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S cGMP Deviations: Out of specification results for micro in hand soap products. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. cGMP Deviations: Out of specification results for micro in hand soap products. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ cGMP Deviations: Out of specification results for micro in hand soap products. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S cGMP Deviations: Out of specification results for micro in hand soap products. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON cGMP Deviations: Out of specification results for micro in hand soap products. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785… cGMP Deviations: Out of specification results for micro in hand soap products. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 20 mg CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit Class IIFDA’s classDec 11, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereOhio, Pennsylvania and Puerto Rico
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 30 mg CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit Class IIFDA’s classDec 11, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereOhio, Pennsylvania and Puerto Rico
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 60 mg CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit Class IIFDA’s classDec 11, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereOhio, Pennsylvania and Puerto Rico
- Medicine recall Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets Labeling: Not Elsewhere Classified - Wrong NDC number Class IIIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Sunitinib Malate Capsules, 12.5 mg, 28-count bottles Labeling: Label Mix-Up Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Sunitinib Malate Capsules, 25 mg, 28-count bottles Labeling: Label Mix-Up Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC… CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Tablets, 30 mg, 30-count bottle CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Tablets, 60 mg, 30-count bottle CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Tablets, 90 mg, 30-count bottle CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl CGMP Deviations: Inconsistency in the water systems. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedDec 11, 2024ClassClass IIStatusOngoingWhereCalifornia
- Medicine recall Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ABSORBINE jr cGMP Deviations Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box cGMP Deviations Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7% cGMP Deviations Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24 cGMP Deviations Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box cGMP Deviations Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box cGMP Deviations Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box… cGMP Deviations Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per… cGMP Deviations Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box cGMP Deviations Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box cGMP Deviations Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box cGMP Deviations Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL CGMP violations. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medicine recall LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. CGMP violations. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medicine recall Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5% cGMP Deviations Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall IBU (ibuprofen) 600 mg tablets, 500-count bottle Failed Tablet/Capsule Specifications Class IIIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Triamcinolone Acetonide Cream USP, 0.025%, 1 LB Subpotent and Superpotent Drug. Class IIIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite… Failed Impurity/Degradation Specifications Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusTerminatedWhereNationwide
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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