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 Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 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 TOBREX 0.3% 3.5GM OPTH 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 Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile 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 CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML 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 Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister… 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 Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths 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 Lamotrigine Extended-Release Tablets 250 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 ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES 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 HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL 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 RISPERIDONE 1MG/ML 30ML 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 Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel 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 Benzoyl Peroxide 10% Acne Medication Wash 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 Polyethylene Glycol 3350 Powder for Solution, Laxative 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 POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Packet- Newt Wt. 0.5 oz 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 Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each 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 LORATADINE 10MG 100 ND 24H 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 Cetirizine Hydrochloride Tablets, 10 mg, 300 Count 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 Podofilox Topical Solution 0.5% 3.5ML 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 HYDROCORTISONE ACET 30MG 12 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 Triamcinolone Acetonide Ointment, USP, 0.025% 80g 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 LYRICA (pregabalin) capsules, 200mg 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 Methotrexate Injection, USP 50 mg/2mL 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 Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks 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 Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks 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 Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week 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 LEVOXYL Tablets, USD, 150MCG, 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 PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML 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 Nature’s Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietary Supplements Carefully Designed… 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 Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators 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 Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate… 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 Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled Syringe 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 medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML 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 Cefazolin for Injection, USP 1 gram per vial 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 HYDROCORTISONE 1% 30gm cream 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 Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units 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 Collagenase Santyl Ointment 250 units/g 30 grams 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 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 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 COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-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 Trokendi XR (topiramate) extended-release capsules 100 mg 30 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 Colcrys (colchicine, USP) tablets 0.6 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 Children’s Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ 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 Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered… 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 NEOMYCIN SULF TABLETS, USP, 500mg, 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 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 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 PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) 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 EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and… 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 EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors… 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 Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card Dispensers, 28 tablets each 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
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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