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 EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30 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 Theophylline (Anhydrous) Extended-Release Tablets 400 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 Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 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 Hydrocortisone Ointment USP 1% Maximum Strength 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 FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg… 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 bupropion Hydrochloride Tablets, USP 75 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 AcetaZOLAMIDE Tablets, USP 125 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 Calcium Acetate Capsules 667 mg 200 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 LITHIUM CARB 150MG 100 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 LEUCOVORIN 15MG 24 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 Levofloxacin Injection 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 TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 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 Enbrace HR 30 ct 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 Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 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 INVEGA SUSTENNA 156MG/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 Auryxia (ferric citrate) tablets 210 mg* 200 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 Livalo (pitavastatin) tablets 2 mg* 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 PHENTERMINE HCL 30MG 100 C4 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 PHENTERMINE HCL 37.5MG 100 C4 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 Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 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 Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For… 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 SILADRYL 12.5/5ML 118ML SF AF 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 Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 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 NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl 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 TRI-LO-MARZIA 0.180MG/0.025MG 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 Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 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 TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD 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 MICONAZOLE 7 2% 45GM APL 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 Banophen Diphenhydramine HCl 25 mg Antihistamine 100 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 Acne Medication Benzoyl Peroxide Gel USP, 5% 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 VITAMIN D3 50MCG 100 SOFTGELS 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 VITAMIN D3 25MCG 90 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 VITAMIN D3 25MCG 180 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 DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM 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 WASH 5% 148ML 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 VITAMIN D3 50MCG 100 CALC 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 CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 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 PEDIA-LAX 66ML 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 Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant 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 Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant 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 Steglatro (ertugliflozin) 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 ASMANEX TWST 220MCG 60INH PWD 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 Levothyroxine Sodium Tablets, USP 125 mcg 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 Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day 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 Auto-Injectors in all strengths, packs and styles 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 Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 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 NAT B VIT D3 2000U 100 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 Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 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
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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