Medicines, 2023
Shortlist up to four to read them side by side.
1,252 medicine recalls FDA’s Enforcement Report published in 2023, 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.
1,252of 1,252 medicine recallsshown with your filters
The list
- Medicine recall VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportMissourithe one state its words name PublishedMay 24, 2023ClassClass IIStatusOngoingWhereMissouri
- Medicine recall Atovaquone Oral Suspension USP, 750 mg/5 mL Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 17, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 17, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin… Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable. Class IIFDA’s classMay 17, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 17, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Gabapentin Tablets, USP 600 mg Product mixup: one foreign tablet found in product. Class IIIFDA’s classMay 17, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 17, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine Patch 5%, 1 patch Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet… Class IIIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Montelukast Sodium USP, 10 mg, 30 count-bottles CGMP deviations. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Simvastatin USP, 10 mg CGMP deviations. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glimepiride USP, 4 mg, 90 count-bottles CGMP deviations. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Simvastatin USP 20 mg CGMP deviations. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Simvastatin USP 40 mg CGMP deviations. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereFlorida, Georgia and Texas
- Medicine recall Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) CGMP deviation: product outside labeled storage temperature requirements. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets CGMP deviation: product outside labeled storage temperature requirements. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever,… CGMP deviation: product outside labeled storage temperature requirements. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count… CGMP deviation: product outside labeled storage temperature requirements. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pro Power Knight Plus capsule, 2550mg, 1-count blister card Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall NUX Male Enhancement capsule, 1-count blister card Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx Marketed Without an Approved NDA/ANDA Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dianeal Low Calcium Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. Class IIIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 3, 2023ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. Class IIIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 3, 2023ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. Class IIIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 3, 2023ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. Class IIIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 3, 2023ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles CGMP Deviations Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles CGMP Deviations Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Doxazosin Tablets, USP, 4mg, 30-count bottles CGMP Deviations Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Glimepiride Tablets, USP 2mg CGMP Deviations Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Glimepiride Tablets, USP 4mg CGMP Deviations Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Tadalafil Tablets, USP 20 mg CGMP Deviations Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Tadalafil Tablets, USP 5 mg, 30-count bottles CGMP Deviations Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL Subpotent Drug: Out of specification results for low potency was obtained. Class IIIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL,… Presence of Particulate Matter: A piece of glass was found in a prefilled syringe. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets Failed Dissolution Specifications: Out of specification dissolution results above specified values. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall C-Semaglutide 5mg/mL injection, 0.5mL vials Lack of assurance of sterility. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportMississippithe one state its words name PublishedApr 26, 2023ClassClass IIStatusOngoingWhereMississippi
- Medicine recall Aripiprazole Tablets, USP, 20 mg Out of specification (OOS) for Spectroscopic Identification test by IR. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine… Class IIIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles CGMP Deviations: Discoloration Class IIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Bevacizumab 2.5 mg/0.1 mL, Solution for Injection Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect. Class IIIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February… Class IIIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL Labeling; Incorrect NDC number on outer carton of product. Class IIIFDA’s classApr 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2023ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Testosterone Cypionate Injection, USP, CIII, 200 mg/mL cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aripiprazole 5mg tablets, 30-count bottles cGMP Deviations Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atorvastatin 10 mg tablets cGMP Deviations Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Doxazosin 2 mg tablets cGMP Deviations Class IIFDA’s classApr 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2023ClassClass 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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