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 Thiamine HCl Injection, USP 200 mg/2 mL Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901. Class IIIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle Presence of Foreign Tablets/Capsules Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusCompletedWhereNationwide
- Medicine recall 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 9, 2021ClassClass IStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall 1% Lidocaine HCl Injection, USP, 300 mg/30 mL Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 9, 2021ClassClass IStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Olmesartan Medoxomil Tablets, USP, 20 mg Presence of Foreign Tablet/Capsule Class IIIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 2, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 2, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 2, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall NP Thyroid 15 Thyroid Tablets, USP 1/4 grain Subpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 2, 2021ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall NP Thyroid 30 Thyroid Tablets, USP 1/2 grain Subpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 2, 2021ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall NP Thyroid 60 Thyroid Tablets, USP 1 grain Subpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 2, 2021ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain Subpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 2, 2021ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall NP Thyroid 120 Thyroid Tablets, USP 2 grain Subpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 2, 2021ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall THERAPEUTIC M 130 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 NIACIN 250MG 110 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 Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP 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 Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days 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 Norvir Ritonavir Tablets 100 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 Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations 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 METHOCARBAMOL 500MG 500 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 FENOFIBRATE CAPSULES, UPS 67MG 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 OFLOXACIN 0.3% 5ML 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 LIDOCAINE HCL VISC 2% 100ML 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 Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 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 COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/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 Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 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 BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML 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 Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only 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 UBRELVY 100MG 10UD CPLT 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 RESTASIS 0.05%30X 0.4ML OPTH PF 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 Linzess (linaclotide) capsules 72 mcg/capsule 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 Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 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 Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 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 Vraylar (cariprazine) capsules 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 Nitrofurantoin Macrocrystals Capsules 25 mg 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 BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLINGUAL FILM 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 Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after… 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 ERYTHROMYCIN TABLETS, USP 250MG 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 TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML 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 ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES 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 Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL 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 Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Application In The Eye 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 Edarbi (azilsartan medoxomil) tablets 80 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 edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 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 edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 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 GEMCITABINE INJECTION 200MG/5.26ML 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 Brilinta ticagrelar tablets 60 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 Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation… 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 xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 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
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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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