Medicines, 2020
Shortlist up to four to read them side by side.
1,035 medicine recalls FDA’s Enforcement Report published in 2020, 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.
1,035of 1,035 medicine recallsshown with your filters
The list
- Medicine recall Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5%… CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as… Class IIIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf… Class IIIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf… Class IIIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf… Class IIIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification. Class IIIFDA’s classJul 15, 2020in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 15, 2020ClassClass IIIStatusTerminatedWherePuerto Rico
- Medicine recall Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification. Class IIIFDA’s classJul 15, 2020in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 15, 2020ClassClass IIIStatusTerminatedWherePuerto Rico
- Medicine recall Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only Defective Container: Market complaints of missing rubber stoppers from drug vial. Class IIFDA’s classJul 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control. Class IIIFDA’s classJul 15, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 15, 2020ClassClass IIIStatusTerminatedWhereKentucky, Mississippi and Ohio
- Medicine recall Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%) Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%) Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%) Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin… Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not… Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 8, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 8, 2020ClassClass IStatusTerminatedWhereFlorida and Maryland
- Medicine recall Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap,… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. Class IIFDA’s classJul 8, 2020in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 8, 2020ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials,… Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded Class IIIFDA’s classJul 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sterile Curcumin, 4mg/mL, 10mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sterile Curcumin 50mg/mL, 10 mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30) CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac Class IIIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications. Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nystatin Cream, USP 100,000 units per gram, 30 grams Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nystatin Cream, USP 100,000 units per gram, 15 grams Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count. Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg Failed Dissolution Specifications Class IIIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Time-Cap Labs, Inc CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic… Class IIIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic… Class IIIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Clozapine Tablets USP tablet, 100mg, 500-count bottle Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg. Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusTerminatedWhereNationwide
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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