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 Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class IIIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class IIIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Clobazam Tablets, 10 mg Presence of Foreign Tablets/Capsules Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count Failed Dissolution Specifications: Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, 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 classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only. Class IIIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Clobazam Tablets, 10 mg Presence of Foreign Tablets/Capsules Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL CGMP Deviations Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Progesterone Injection USP, 500mg per 10 mL Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Colchicine Capsules 0.6 mg, 30-count bottles Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC… CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial… Failed Stability Specifications Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportOhiothe one state its words name PublishedJan 15, 2025ClassClass IIStatusTerminatedWhereOhio
- Medicine recall Levothyroxine Sodium Tablets, Lupin, 75 mcg Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportOhiothe one state its words name PublishedJan 8, 2025ClassClass IIStatusTerminatedWhereOhio
- Medicine recall Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules Failed Dissolution Specifications Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles Failed Impurities/Degradation Specifications Class IIIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles Marketed without an approved NDA/ANDA. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Dapsone Gel 7.5%, 60 g Crystallization Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dapsone Gel 7.5%, 90 g Crystallization Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ketamine inj 50 mg per 1 mL Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall phenylephrine Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ LABELING: LABEL MIX-UP Class IIIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ LABELING: LABEL MIX-UP Class IIIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules USP, 30 mg CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 30 mg CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules USP, 60 mg CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 60 mg CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusCompletedWhereNationwide
- Medicine recall chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 30mg CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 60 mg CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall DULoxetine DR USP, 30 mg, 90-count bottle CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit Class IIFDA’s classJan 1, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 1, 2025ClassClass IIStatusTerminatedWhereFlorida, Mississippi and Wisconsin
- Medicine recall Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and… Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count… CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323 cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole,… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNo state named
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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