Medicines, 2025
Shortlist up to four to read them side by side.
765 medicine recalls FDA’s Enforcement Report published in 2025, 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.
765of 765 medicine recallsshown with your filters
The list
- Medicine recall SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal… Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300… Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall [CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportVirginiathe one state its words name PublishedApr 2, 2025ClassClass IIStatusOngoingWhereVirginia
- Medicine recall 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL Lack of Assurance of Sterility Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Prasugrel Tablets, USP, 5 mg, 30-count bottle Failed Dissolution Specifications - low dissolution results Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules… Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package 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 classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz Chemical contamination: presence of benzene Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz Chemical contamination: presence of benzene Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall PRASUGREL TABLETS, 5 mg, 30 tablet bottles Failed Dissolution Specifications Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large,… Subpotent Drug Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use… Subpotent Drug Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 150 mcg Super-Potent Drug: Out of specification potency results were obtained. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 125 mcg Super-Potent Drug: Out of specification potency results were obtained. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles Presence of foreign tablets/capsules Class IIIFDA’s classMar 19, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 19, 2025ClassClass IIIStatusCompletedWhereOhio, Pennsylvania and Texas
- Medicine recall BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally… CGMP Deviations Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 19, 2025ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Alprostadil Container Description: Amber color bottle CGMP Deviations Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 19, 2025ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black… CGMP Deviations Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 19, 2025ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Chlorambucil Container Description: The product CGMP Deviations Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 19, 2025ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle CGMP Deviations Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 19, 2025ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Voriconazole Container Description: voriconazole The product CGMP Deviations Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 19, 2025ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton,… CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall POTASSIUM CHLORIDE Inj., 20 mEq total Labeling: Label Error on Declared Strength. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall POTASSIUM CHLORIDE Inj., 10 mEq total Labeling: Label Error on Declared Strength. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 60mg CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 30mg CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass 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 classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* Presence of Particulate Matter FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel Chemical Contamination: Presence of benzene. Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment Chemical Contamination: Presence of benzene Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) Chemical Contamination Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) Chemical Contamination Class IIFDA’s classMar 19, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles Failed Dissolution Specifications Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ergocalciferol - Vitamin D Supplement - 10 mcg Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor… Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron… Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nelarabine Injection, 250mg/50mL Failed Impurities/Degradation Specifications Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nelarabine Injection, 250mg/50mL Failed Impurities/Degradation Specifications Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusCompletedWhereNationwide
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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