Medicines, 2014
Shortlist up to four to read them side by side.
1,562 medicine recalls FDA’s Enforcement Report published in 2014, 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.
1,562of 1,562 medicine recallsshown with your filters
The list
- Medicine recall Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine… Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Class IIFDA’s classJan 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg)… Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Class IIFDA’s classJan 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials Presence of Particulate Matter; Glass particulates observed in vials FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall ATOMOXETINE HCL, Capsule, 40 mg Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 40 mg may be potentially mis-labeled as OLANZAPINE, Tablet, 7.5 mg, NDC 60505311203, Pedigree: AD21790_76,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall DULoxetine HCl DR, Capsule, 20 mg Labeling: Label Mixup: DULoxetine HCl DR, Capsule, 20 mg, may be potentially mis-labeled with one of the following drugs: ENTECAVIR, Tablet, 0.5 mg, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall ATOMOXETINE HCL, Capsule, 18 mg Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 18 mg, may be potentially mis-labeled as the following drug: LOVASTATIN, Tablet, 20 mg, NDC 00185007201,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall ATOMOXETINE HCL, Capsule, 80 mg Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 80 mg may be potentially mis-labeled as one of the following drugs: ATOMOXETINE HCL, Capsule, 18 mg, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall RALOXIFENE HCL, Tablet, 60 mg Labeling: Label Mixup: RALOXIFENE HCL, Tablet, 60 mg may be potentially mis-labeled as following drug: ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701;… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall ENTECAVIR, Tablet, 0.5 mg Labeling: Label Mixup: ENTECAVIR, Tablet, 0.5 mg may be potentially mis-labeled as one of the following drugs: ARIPiprazole, Tablet, 2 mg, NDC 59148000613,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall MYCOPHENOLATE MOFETIL, Capsule, 250 mg Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may be potentially mis-labeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall MYCOPHENOLATE MOFETIL, Tablet, 500 mg Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Tablet, 500 mg may be potentially mis-labeled as the following drug: MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units, Over The Counter Labeling: Label Mixup: CALCIUM CARBONATE/CHOLECALCIFEROL, Tablet, 600 mg/800 units may be potentially mis-labeled as the following drug: REPAGLINIDE, Tablet, 1… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall sitaGLIPtin PHOSPHATE, Tablet, 50 mg Labeling: Label Mixup: sitaGLIPtin PHOSPHATE, Tablet, 50 mg may be potentially mis-labeled as one of the following drugs: LACTOBACILLUS, Tablet, 0 mg, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall RALTEGRAVIR, Tablet, 400 mg Labeling: Label Mixup: RALTEGRAVIR, Tablet, 400 mg may be potentially mis-labeled as one of the following drugs: HYDROCORTISONE, Tablet, 5 mg, NDC00603389919,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall MONTELUKAST SODIUM, CHEW Tablet, 4 mg Labeling: Label Mixup: MONTELUKAST SODIUM, CHEW Tablet, 4 mg may be potentially mislabeled as the following drug: DICYCLOMINE HCL, Tablet, 20 mg, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall CARVEDILOL PHOSPHATE ER, Capsule, 20 mg Labeling: Label Mixup: CARVEDILOL PHOSPHATE ER, Capsule, 20 mg may be potentially mislabeled as the following drug: BUMETANIDE, Tablet, 1 mg, NDC 00093423301,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall PANTOPRAZOLE SODIUM DR, Tablet, 20 mg Labeling: Label Mixup: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall SIROLIMUS, Tablet, 1 mg Labeling: Label Mixup: SIROLIMUS, Tablet, 1 mg may be potentially mislabeled as one of the following drugs: PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall TOLTERODINE TARTRATE ER, Capsule, 2 mg Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 2 mg may be potentially mislabeled as one of the following drugs: RANOLAZINE ER , Tablet, 500 mg, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall TOLTERODINE TARTRATE ER, Capsule, 4 mg Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 4 mg may be potentially mislabeled as one of the following drugs: HYDRALAZINE HCL, Tablet, 25 mg, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall DRONEDARONE HCL, Tablet, 400 mg Labeling: Label Mixup: DRONEDARONE HCL, Tablet, 400 mg may be potentially as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as one of the following drugs: ASCORBIC ACID,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units may be potentially mislabeled as the following drug: ASPIRIN/ER DIPYRIDAMOLE,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units Labeling: Label Mixup: PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units may be potentially mislabeled as one of the following drugs: SERTRALINE HCL,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall PROGESTERONE, Capsule, 100 mg Labeling: Label Mixup: PROGESTERONE, Capsule, 100 mg may be potentially mislabeled as the following drug: LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall CALCITRIOL, Capsule, 0.25 mcg Labeling: Label Mixup: CALCITRIOL, Capsule, 0.25 mcg may be potentially as one of the following drugs: ANAGRELIDE HCL, Capsule, 0.5 mg, NDC 00172524160,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall FLECAINIDE ACETATE, Tablet, 100 mg Labeling: Label Mixup: FLECAINIDE ACETATE, Tablet, 100 mg may be potentially mislabeled as the following drug: COLESTIPOL HCL MICRONIZED, Tablet, 1 g, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall LITHIUM CARBONATE ER, Tablet, 225 mg Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg) may be potentially mislabled as one of the following drugs: CYCLOBENZAPRINE HCL,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall LITHIUM CARBONATE ER, Tablet, 450 mg Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 450 mg may be potentially mislabled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall LITHIUM CARBONATE ER, Tablet, 300 mg Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 300 mg may be potentially mislabled as the following drug: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall CILOSTAZOL, Tablet, 100 mg Labeling: Label Mixup: CILOSTAZOL, Tablet, 100 mg may be potentially mislabeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall EXEMESTANE, Tablet, 25 mg Labeling: Label Mixup: EXEMESTANE, Tablet, 25 mg may be potentially mislabeled as the following drug: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall CALCIUM ACETATE, Capsule, 667 mg, Over The Counter Labeling: Label Mixup: CALCIUM ACETATE, Capsule, 667 mg may be potentially mislabeled as one of the following drugs: ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall ACARBOSE, Tablet, 25 mg Labeling: Label Mixup: ACARBOSE, Tablet, 25 mg may be potentially mislabeled as one of the following drugs: ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall BUPRENORPHINE HCL SL, Tablet, 2 mg Labeling: Label Mixup: BUPRENORPHINE HCL SL, Tablet, 2 mg may be potentially mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall azaTHIOprine, Tablet, 50 mg Labeling: Label Mixup: azaTHIOprine, Tablet, 50 mg may have potentially been mislabeled as the following drug: SELENIUM, Tablet, 50 mcg, NDC 00904316260,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall DEXAMETHASONE, Tablet, 1 mg Labeling: Label Mixup: DEXAMETHASONE, Tablet, 1 mg may have potentially been mislabeled as the following drug: VENLAFAXINE HCL ER, Capsule, 150 mg, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall MERCapsuleTOPURINE, Tablet, 50 mg Labeling: Label Mixup: MERCapsuleTOPURINE, Tablet, 50 mg may have potentially been mislabeled as the following drug: ASCORBIC ACID, Tablet, 500 mg, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall EFAVIRENZ, Capsule, 200 mg Labeling: Label Mixup: EFAVIRENZ, Capsule, 200 mg may have potentially been mislabeled as the following drug: metFORMIN HCl, Tablet 500 mg, NDC 23155010201,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall EFAVIRENZ, Tablet, 600 mg Labeling: Label Mixup: EFAVIRENZ, Tablet, 600 mg may have potentially been mislabeled as the following drug: NIACIN ER, Tablet, 500 mg, NDC 00074307490,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall PHENOL, LOZENGE, 29 mg Labeling: Label Mixup: PHENOL, LOZENGE, 29 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall VARENICLINE, Tablet, 0.5 mg Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 0, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall SILDENAFIL CITRATE, Tablet, 25 mg Labeling: Label Mixup: SILDENAFIL CITRATE, Tablet, 25 mg may have potentially been mislabeled as the following drug: PHENobarbital/ HYOSCYAMINE/ ATROPINE/… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall PREGABALIN, Capsule, 25 mg Labeling: Label Mixup: PREGABALIN, Capsule, 25 mg may have potentially been mislabeled as one of the following drugs: CHOLECALCIFEROL, Capsule, 2000 units, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall PREGABALIN, Capsule, 200 mg Labeling: Label Mixup: PREGABALIN, Capsule, 200 mg may have potentially been mislabeled as one of the following drugs: LOSARTAN POTASSIUM, Tablet, 50 mg, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall PHENYTOIN SODIUM ER, Capsule, 30 mg Labeling: Label Mixup: PHENYTOIN SODIUM ER, Capsule, 30 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 450 mg,… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall NIACIN ER, Tablet, 500 mg Labeling: Label Mixup: NIACIN ER, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: CHOLECALCIFEROL, Capsule, 50000 units, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
- Medicine recall PARICALCITOL, Capsule, 1 mcg Labeling: Label Mixup: PARICALCITOL, Capsule, 1 mcg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 500 mg, NDC… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereArizona, California, Oregon and Washington
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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