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 xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 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 IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML 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 Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose 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 AMOXICILLIN 500MG 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 ONDANSETRON HCL 4MG 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 ESZOPICLONE 3MG 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 Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 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 LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM 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 BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL 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 MURO-128 2% 15ML 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 TOBRAMY/DEX 0.3-0.1% 10ML 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 DEXAMETH SOD PHOS 0.1% 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 Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film 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 Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film 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 SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 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 NURTEC ODT (RIMEGEPANT) 75MG 8 BPK 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 CATAPRES-TTS-2 1X4 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 Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per… 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 ATROVENT HFA 17MCG 12.9GM 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 Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/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 Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 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 Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 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 Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 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 Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 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 PRAVACHOL 40MG 90 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 Valsartan Tablets USP 40 mg 30 Scored 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 Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) 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 Meloxicam Tablets, USP 7.5 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 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 CIPROFLOX/D5W 400/200 24X200ML 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 Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 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 Iron 100 with Vitamin C Tablets Dietary Supplement 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 BENICAR 40MG 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 PREGABALIN CAPSULES 300MG 90 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 Phenobarbital Tablets, USP 32.4 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 Ivermectin Tablets USP 3 mg 20 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 Banzel (rufinamide) tablets 200 mg 120 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 Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two 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 SYRUP 10-30-2MG/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 Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women… 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 cathflo activase (ALTEPLASE) 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 FLOVENT DISKUS 100MCG 60 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 ADVAIR HFA 45-21MCG 12GM 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 ARNUITY ELLIPTA 100MCG 30INH 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 Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of… 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 TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60 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 Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 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 Verapamil Hydrochloride Extended-Release Tablets USP 120 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
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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