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 Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps Label mix-up: Carton incorrectly labeled. Class IIIFDA’s classAug 14, 2024in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedAug 14, 2024ClassClass IIIStatusTerminatedWhereIllinois
- Medicine recall PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral… Defective container: potential for non-sealed pouches which can lead to product leakage. Class IIIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Methotrexate Tablets, USP, 2.5mg, 100-count Bottle Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle. Class IIIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIIStatusCompletedWhereNationwide
- Medicine recall Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use… Lack of Assurance of Sterility Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gabapentin Tablets, USP, 600 mg, 500-count bottles Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets Class IIFDA’s classAug 14, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium Chloride Extended-Release Capsules, USP Failed Dissolution Specifications FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Glenmark, Azelaic Acid Gel, 15 %, 50 grams CGMP Deviations Class IIFDA’s classAug 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 7, 2024ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5… 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 classAug 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Progesterone Injection, USP, 500 mg per 10 mL Presence of Particulate Matter: Complaint received of a glass particle in the vial. Class IIFDA’s classAug 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class IIIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Nature’s Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class IIIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class IIIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class IIIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals. Class IIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic medicines, Washington… Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C. Class IIIFDA’s classJul 31, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2024ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg Failed Dissolution Specifications Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2024ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Oatmeal Daily Moisturizing Body Lotion Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial Presence of particulate matter: glass Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJul 24, 2024ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall Fludrocortisone Acetate Tablets, USP 0.1mg Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles Failed Impurities/Degradation Specifications Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles Failed Impurities/Degradation Specifications Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Potassium Chloride Extended-Release Capsules, USP Failed Dissolution Specifications FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Potassium Chloride Extended-Release Capsules, USP Failed Dissolution Specifications FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Potassium Chloride Extended-Release Capsules, USP CGMP Deviations Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Potassium Chloride Extended-Release Capsules, USP CGMP Deviations Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay “safe… This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IStatusTerminatedWhereNationwide
- Medicine recall STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium Chloride Micro 10mEq K CGMP Deviations: Out of specification for dissolution Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pravastatin Sodium Tablets, USP 80mg Failed Dissolution Specifications: results below specifications Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dianeal Low Calcium Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30 Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold) FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30 CGMP Deviations Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets Failed Dissolution Specifications; the product is dissolving faster than the specified limits. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Blemfree All Day Lotion (salicylic acid 0.5% w/w) CGMP Deviations: Manufactured without following Current Good Manufacturing Practises. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL) Cross contamination with other products. Class IIIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Verapamil Hydrochloride Injection, USP 10 mg/4 mL Cross contamination with other products. Class IIIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Lidocaine HCL Injection, USP 2% 200mg/10mL Subpotent Drug: reduced efficacy for epinephrine Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial Cross contamination with other products Class IIIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2024ClassClass IIIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial Cross contamination with other products Class IIIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2024ClassClass IIIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit. Class IIIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc.,… CGMP Deviations and Presence of Particulate Matter: Glass Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) CGMP deviations Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%) CGMP deviations Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ CGMP deviations Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 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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