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 5, 2026.
1,252of 1,252 medicine recallsshown with your filters
The list
- Medicine recall TING 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder Chemical Contamination; presence of benzene. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 27, 2023ClassClass IStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Selenium Sulfide 2.25% Shampoo, 180mL bottle CGMP Deviations: Stability data does not support expiry date. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNew Jersey
- Medicine recall Phenytoin Oral Suspension, USP, 100 mg/4 mL Failed Content Uniformity Specifications FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNo state named
- Medicine recall NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNo state named
- Medicine recall NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNo state named
- Medicine recall NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. Class IIFDA’s classDec 27, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 27, 2023ClassClass IIStatusOngoingWhereNo state named
- Medicine recall THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportFloridathe one state its words name PublishedDec 27, 2023ClassClass IStatusOngoingWhereFlorida
- Medicine recall Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal Chemical contamination: Presence of benzene FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Penicillamine Tablets USP 250 mg, 100-count bottle Failed Dissolution Specifications Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 20, 2023ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Votrient (pazopanib) 200 mg tablets, 120-count bottle Failed Dissolution Specifications Class IIIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIIStatusCompletedWhereNationwide
- Medicine recall Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle Failed Impurities/Degradation Specifications Class IIFDA’s classDec 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle Failed Dissolution Specifications Class IIIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dr. Ergin’s SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose… MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical… Product Mix-up: Incorrect Product Formulation Class IIIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL Lack of assurance of sterility. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedDec 13, 2023ClassClass IIStatusCompletedWherePennsylvania
- Medicine recall KinderMed KIDS’ PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor,… Failed Impurities/Degradation Specifications Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall KinderMed INFANTS’ PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry… Failed Impurities/Degradation Specifications Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Ondansetron Injection, USP, 4 mg/2 mL Failed pH Specifications Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL STAQ Pharma Inc. Class IIFDA’s classDec 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Paroxetine Hydrochloride Tablets USP Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Paroxetine Hydrochloride Tablets USP Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Paroxetine Hydrochloride Tablets USP Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Paroxetine Hydrochloride Tablets USP Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Indomethacin 25mg Capsules, USP, 100-count bottle Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Naproxen Tablets, USP 250mg, 100-count bottle Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Tropicamide 1% Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper Class IIIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Aminocaproic Acid Oral Solution, 0.25 grams/mL Failed Excipient Specifications: high content of ethylene glycol (EG) Class IIIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Gel, 1.62% CIII (Alcohol 80% v/v) OOS for viscosity Class IIIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall PAROXETINE tablets, USP, 10 mg Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PAROXETINE tablets, USP, 20 mg Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PAROXETINE tablets, USP, 40 mg Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. Class IIFDA’s classDec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Artri King Reforzado con Origa y Omega 3 tablets Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Reumo Flex caplets Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Kuka Flex Forte caplets Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Polyvinyl Alcohol 1.4% Lubricating Eye Drops Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3% Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportOklahomathe one state its words name PublishedNov 29, 2023ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportOklahomathe one state its words name PublishedNov 29, 2023ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts. Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportOklahomathe one state its words name PublishedNov 29, 2023ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time… Class IIIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Buspirone Hydrochloride Tabs USP 10 mg Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots Class IIIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lisinopril Tablets USP 20 mg Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots Class IIIFDA’s classNov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Tiglutik (riluzole) Oral Suspension 50 mg/10 mL Failed Viscosity Specifications: Out-of-specification test results for viscosity Class IIFDA’s classNov 29, 2023in FDA’s Enforcement ReportTennesseethe one state its words name PublishedNov 29, 2023ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL Presence of Particulate Matter: Silicone FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IStatusOngoingWhereNationwide
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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