Medicines, 2021
Shortlist up to four to read them side by side.
1,016 medicine recalls FDA’s Enforcement Report published in 2021, 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.
1,016of 1,016 medicine recallsshown with your filters
The list
- Medicine recall Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Sulindac Tablets, USP, 200mg 100-count bottles CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Darifenacin Extended-release Tablets 7.5 mg 30 Tablets CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Darifenacin Extended-release Tablets 15 mg 30 Tablets CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules 90 Capsules CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall INTEGRA 325/40/3mg 90-count bottle CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Briviact (brivaracetam) tablets 50 mg, 60-count bottle CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Amantadine Hydrochloride Tablets 100 mg 100-count bottle CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall HALOPERIDOL TABLETS 20mg, USP, 100-count bottle CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Corgard (nadolol tablets, USP) 40 mg 100 Tablets CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall CYANOCOBAL Injection 1000MCG/ML 25X1ML CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Enalapril Maleate Tablets, USP 2.5 mg 100 tablets CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJun 2, 2021ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Atorvastatin Calcium Tablets, USP 10 mg* Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities Class IIIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 2, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial Lack of Assurance of Sterility Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials Lack of Assurance of Sterility Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial Lack of Assurance of Sterility Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metoclopramide Injection USP, 10 mg/2 mL Lack of Assurance of Sterility Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials Lack of Assurance of Sterility Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Asenapine Sublingual Tablets, 5 mg Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent Class IIIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Asenapine Sublingual Tablets, 10 mg Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent Class IIIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall PremierZen Extreme 3000 Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall PremierZen Black 5000 Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Triple SupremeZen Plus 3500 Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton Presence of Particulate Matter: particulate matter identified as an insect in one vial. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportFloridathe one state its words name PublishedMay 26, 2021ClassClass IIStatusOngoingWhereFlorida
- Medicine recall Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle Failed Impurities/Degradation Specifications Class IIIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP Subpotent Drug Class IIIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Thumbs Up 7 Blue 69K, 10 capsules Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles Subpotent Drug Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials Subpotent and Presence of Particulates . Class IIIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Metformin HCl Extended-Release Tablets, USP, 500 mg Presence of foreign substance: identified as activated carbon. Class IIFDA’s classMay 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 19, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BD ChloraPrep Hi-Lite Orange 26 mL Applicator Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 19, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 19, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals,… Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 12, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 12, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical… Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 12, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 12, 2021ClassClass IStatusTerminatedWhereCalifornia and Florida
- Medicine recall Thumbs Up 7 Red 70K, 10 count blister pack cartons Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil. Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 12, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acyclovir Tablets, USP, 400 mg, 100 Tablets Labeling: Incorrect or Missing Lot and/or Exp Date Class IIIFDA’s classMay 12, 2021in FDA’s Enforcement ReportOhiothe one state its words name PublishedMay 12, 2021ClassClass IIIStatusTerminatedWhereOhio
- Medicine recall IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 12, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 12, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Burro en Primavera, 2 capsules Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 12, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Imperial Platinum 2000, 1 capsule Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. Class IIFDA’s classMay 12, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 12, 2021ClassClass 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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