Medicines
Shortlist up to four to read them side by side.
704 medicine recalls FDA’s Enforcement Report published in 2026, the newest year, 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.
704of 704 medicine recallsshown with your filters
The list
- Medicine recall TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag CGMP Deviations:Noted during FDA inspection Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag CGMP Deviations:Noted during FDA inspection Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag CGMP Deviations:Noted during FDA inspection Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz Lack of assurance of sterility. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. Class IIFDA’s classAug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Kian Pee Wan Capsules, 30-count bottles Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 19, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 19, 2026ClassClass IStatusOngoingWhereNo state named
- Medicine recall Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl… Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IStatusOngoingWhereNationwide
- Medicine recall Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL… Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IStatusOngoingWhereNationwide
- Medicine recall Cefazolin in Dextrose, Injection, USP, 2g / 100mL Presence of Particulate Matter FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 19, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2026ClassClass IStatusOngoingWhereNationwide
- Medicine recall Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles shortfill; reports of empty capsules. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8… Incorrect Product Formulation Class IIIFDA’s classAug 12, 2026in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedAug 12, 2026ClassClass IIIStatusOngoingWhereGeorgia
- Medicine recall Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial Presence of Particulate Matter; identified as stainless steel FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IStatusOngoingWhereNationwide
- Medicine recall Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial Presence of Particulate Matter; identified as stainless steel FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IStatusOngoingWhereNationwide
- Medicine recall Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton Presence of precipitate Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dabigatran Etexilate Capsules, 150 mg, 60-count Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for… Class IIIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Dabigatran Etexilate Capsules, 75 mg, 60-count Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for… Class IIIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Dabigatran Etexilate Capsules, 75 mg, 30-count Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for… Class IIIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 25 mcg Subpotent Drug Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 50 mcg Subpotent Drug Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 75 mcg Subpotent Drug Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 88 mcg Subpotent Drug Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 112 mcg Subpotent Drug Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 125 mcg Subpotent Drug Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 150 mcg Subpotent Drug Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 25 mcg Subpotent Drug Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 50 mcg Subpotent Drug Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 75 mcg Subpotent Drug Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 125 mcg Subpotent Drug Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 150 mcg Subpotent Drug Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan Class IIIFDA’s classJul 29, 2026in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJul 29, 2026ClassClass IIIStatusOngoingWhereTennessee
- Medicine recall Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%),… Lack of Assurance of Sterility Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL… Lack of Assurance of Sterility Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN… Lack of Assurance of Sterility Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%),… Lack of Assurance of Sterility Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ Lack of Assurance of Sterility Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ Lack of Assurance of Sterility Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ Lack of Assurance of Sterility Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL… Lack of Assurance of Sterility Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT) Presence of Precipitate: medication was crystallizing and particles floating in the bottle Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Glycopyrrolate Injection, USP, 1 mg per 5 mL Presence of Particulate Matter: Hair was found in product Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL Presence of Particulate Matter: Hair was found in products Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL Presence of Particulate Matter: Hair was found in products Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL Presence of Particulate Matter: Hair was found in products Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL Presence of Particulate Matter: Hair was found in products Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2026ClassClass 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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