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 Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%) 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, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) 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, Ass Kisser 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, Asana Kisser, (Camphor 1.35%, Menthol 2.86%) 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, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) CGMP deviations Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial Subpotent drug: out of specification results Class IIIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Eszopiclone Tablets, USP 1mg CIV, 30-count bottle Failed Impurities/Degradation Specifications: Related Substances Class IIIFDA’s classJul 10, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 10, 2024ClassClass IIIStatusOngoingWhereMississippi and Ohio
- Medicine recall Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Allopurinol Tablets, USP 300mg, 100 Tablets per bottle Presence of foreign substance. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 10, 2024ClassClass IIStatusTerminatedWhereIllinois, Mississippi and Ohio
- Medicine recall Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution. Class IIFDA’s classJul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall To the Moon Capsules, Horny Goat Weed, 1000 mg Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly,… Presence of Foreign Substance; Broken metal piece found embedded in tablet. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit… Lack of Assurance of Sterility-The potential for incomplete crimp seals. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Labetalol Hydrochloride Injection, USP, 20 mg/4 mL Lack of Assurance of Sterility-The potential for incomplete crimp seals. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle Discoloration: Brownish tablets Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJul 3, 2024ClassClass IIStatusOngoingWhereMichigan
- Medicine recall Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 30mg CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit. Class IIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12… Sub-potent Drug Class IIIFDA’s classJul 3, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Eptifibatide injection 20mg/10mL Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer. Class IIIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Little Remedies Gas Relief Drops (Simethicone/Antigas) cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error. Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 26, 2024ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol, Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cefixime for Oral Suspension USP 200 mg/5 mL Failed Content Uniformity Specifications Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Petroleum Jelly, White Petrolatum USP Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles Subpotent Drug Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class IIFDA’s classJun 26, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles Product Mix Up. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL Lack of Assurance of Sterility Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL Lack of Assurance of Sterility Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Phenazopyridine HCl, 100mg tablets, 6 count bottles Product Mix Up. Class IIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 19, 2024ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses Defective Container Class IIIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses Defective Container Class IIIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses Defective Container Class IIIFDA’s classJun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Docetaxel Injection, USP, 80 mg per 8 mL Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Docetaxel Injection, USP, 160 mg per 16 mL Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 19, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2024ClassClass IStatusOngoingWhereNationwide
- Medicine recall Rizatriptan Benzoate Tablets USP, 5mg, 18 CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rizatriptan Benzoate Tablets USP, 10 mg, 18 CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. Class IIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cephalexin for Oral Suspension, USP, 125mg per 5mL Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label ‘Each Tablet contains’ instead of ‘Each Bottle… Class IIIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Cephalexin for Oral Suspension, USP, 125mg per 5mL Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g’ instead of Each Bottle contains:… Class IIIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Cephalexin for Oral Suspension, USP, 250mg/ 5mL Labeling: Not Elsewhere Classified: Back Label states ‘Each contains: cephalexin monohydrate, USP equivalent to 5g’ instead of Each Bottle contains: cephalexin… Class IIIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Cephalexin for Oral Suspension, USP, 250mg per 5mL Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g’ on the back label instead of Each Bottle… Class IIIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Cephalexin for Oral Suspension, USP, 250mg/5mL Labeling: Not Elsewhere Classified: Back Label states ‘Each contains: cephalexin monohydrate, USP equivalent to 5g’ instead of Each Bottle contains: cephalexin… Class IIIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Pregabalin Capsules 50mg, 1000-count bottle Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of… Class IIIFDA’s classJun 12, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2024ClassClass IIIStatusOngoingWhereNationwide
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.”
Your shortlist0 of 4
Add one more to compare.