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 Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 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
- Medicine recall BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe Lack of Sterility Assurance Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed… Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive). Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box,… cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lisinopril Tablets, USP 10 mg, 90 tablets per bottle Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet. Class IIFDA’s classNov 27, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Trinity Gold Nutrition, 60 Capsule, 30 day Supply Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Hydralazine HCl Tablets, USP, 25mg Failed Impurities/Degradation Specifications; during routine stability testing for impurities. Class IIIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution Subpotent Drug Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg) Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. Class IIIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 13, 2024ClassClass IIIStatusOngoingWhereNo state named
- Medicine recall Kids’ Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg) Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. Class IIIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 13, 2024ClassClass IIIStatusOngoingWhereNo state named
- 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 classNov 13, 2024in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNew Jersey
- Medicine recall Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle Failed Impurities/Degradation Specification Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles Failed Impurities/Degradation Specification Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dapsone Gel 7.5%, 60 gram pump Crystallization Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Regadenoson Injection, 0.4 mg/5 mL Labeling: Missing Label Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ascorbic Acid Inj Presence of Particulate Matter: Presence of glass particulates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2024ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing. Class IIFDA’s classNov 13, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Tablets, 30 mg, 30-count bottle CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Tablets, 60 mg, 30-count bottles CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Tablets, 90 mg, 30-count bottle CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Chlorpheniramine Maleate 4 mg tablets, 24-count bottle Superpotent Drug: Stability failure for assay at 6 months test time-point. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 6, 2024ClassClass IIStatusTerminatedWhereMissouri and Ohio
- Medicine recall Cinacalcet Tablets 30 mg CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 6, 2024ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Cinacalcet Tablets, 60 mg CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 6, 2024ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Cinacalcet Tablets, 90 mg CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Class IIFDA’s classNov 6, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 6, 2024ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag CGMP violations Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag cGMP violations Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag cGMP violations Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag cGMP violations Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag cGMP violations Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag cGMP violations Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag cGMP violations Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag cGMP violations Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag cGMP violations Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag cGMP violations Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AK Forte Ortiga y Omega 3 Cont Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ CGMP Deviations Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 20mg CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Cisplatin Injection, 100mg/100mL Failed Impurities/Degradation Specifications. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dapsone Gel 7.5%, 60 gram pump Crystallization Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNew York
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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