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 5, 2026.
1,035of 1,035 medicine recallsshown with your filters
The list
- Medicine recall Aripiprazole Tablets, USP 15 mg tablets Failed Dissolution Specifications: Out of specification for dissolution. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing. Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle Failed Dissolution Specifications Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Union (black) salve CGMP Deviations Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall White Liniment CGMP Deviations Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vapor Ointment CGMP Deviations Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bupivacaine Hydrochloride Presence of particulate matter in solution - black and transparent particles Class IIFDA’s classNov 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 18, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Chlorhexidine Gluconate 20% 0012 Medichem, S.A Discoloration. Class IIFDA’s classNov 11, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereAlabama, New Jersey and Texas
- Medicine recall Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 11, 2020ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medicine recall Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30) CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 11, 2020ClassClass IIStatusOngoingWhereNationwide, and Indiana named
- Medicine recall Metformin HCL E/R 500 mg, 90 Tabs CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportFloridathe one state its words name PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall metformin HCL ER 500 mg, a) 30 tablets CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) Class IIFDA’s classNov 11, 2020in FDA’s Enforcement Report16 statesnamed in where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Minnesota, North Carolina, New York, Oklahoma, Oregon and Wisconsin
- Medicine recall metformin HCL ER 750 mg CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) Class IIFDA’s classNov 11, 2020in FDA’s Enforcement Report16 statesnamed in where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Minnesota, North Carolina, New York, Oklahoma, Oregon and Wisconsin
- Medicine recall Time-Cap Labs, Inc CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Time-Cap Labs, Inc CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluocinonide Ointment USP 0.05% Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity. Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fluent Children’s Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4… Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups. Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNew Jersey
- Medicine recall Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count Subpotent Class IIIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton Failed Dissolution Specification Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton Failed Dissolution Specification Class IIFDA’s classNov 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedNov 4, 2020ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle An extraneous peak was observed for dissolution testing. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle An extraneous peak was observed for dissolution testing. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle An extraneous peak was observed for dissolution testing. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes SUBPOTENT DRUG Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NP Thyroid 15,Thyroid Tablets, USP 1/4 grain Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall NP Thyroid 120, Thyroid Tablets, USP 2 grain Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Panagel Hand Sanitizer, 70% Alcohol,16 Fl CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Desflurane, USP Liquid for Inhalation, 240 mL DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking. Class IIIFDA’s classOct 28, 2020in FDA’s Enforcement ReportColoradothe one state its words name PublishedOct 28, 2020ClassClass IIIStatusTerminatedWhereColorado
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine… Labeling: Incorrect expiration date. Class IIIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine… Labeling: Incorrect expiration date. Class IIIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine… Labeling: Incorrect expiration date. Class IIIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine… Labeling: Incorrect expiration date. Class IIIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine… Labeling: Incorrect expiration date. Class IIIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine… Labeling: Incorrect expiration date. Class IIIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg Out-of-specification organic impurity results obtained during routine stability testing. Class IIIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl. Class IIIFDA’s classOct 21, 2020in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedOct 21, 2020ClassClass IIIStatusTerminatedWherePennsylvania
- Medicine recall Smart Care HAND SANITIZER, Ethyl Alcohol 62% Labeling: Not Elsewhere Classified. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 21, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 21, 2020ClassClass IStatusTerminatedWhereCalifornia and Illinois
- Medicine recall Nature-Throid 1 GR CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereArizona and Oklahoma
- Medicine recall Diethylpropion, 25 mg tablets cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereCalifornia, Idaho, Illinois, Oklahoma and Rhode Island
- Medicine recall Diethylpropion, 75 mg tablets cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. Class IIFDA’s classOct 14, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 14, 2020ClassClass IIStatusTerminatedWhereCalifornia, Idaho, Illinois, Oklahoma and Rhode Island
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.
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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