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 AMANTADINE HCL, Capsule, 100 mg Labeling: Label Mixup: AMANTADINE HCL, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: ACARBOSE, 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 TERAZOSIN HCL, Capsule, 5 mg Labeling: Label Mixup: TERAZOSIN HCL, Capsule, 5 mg may have potentially been mislabeled as the following drug: DOXAZOSIN MESYLATE, Tablet, 1 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, Capsule, 250 mg Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet,… 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 TACROLIMUS, Capsule, 0.5 mg Labeling: Label Mixup: TACROLIMUS, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: CINACALCET HCL, Tablet, 30 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 TACROLIMUS, Capsule, 1 mg Labeling: Label Mixup: TACROLIMUS, Capsule, 1 mg may have potentially been mislabeled as one of the following drugs: BISOPROLOL FUMARATE, Tablet, 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 methylPREDNISolone, Tablet, 4 mg Labeling: Label Mixup: methylPREDNISolone, Tablet, 4 mg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 112… 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 LEVOTHYROXINE SODIUM, Tablet, 88 mcg Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as one of the following drugs: clomiPRAMINE HCl, Capsule, 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 LEVOTHYROXINE SODIUM, Tablet, 137 mcg Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 137 mcg may have potentially been mislabeled as the following drug: OMEGA-3 FATTY ACID, Capsule, 1000 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 BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: CYANOCOBALAMIN, Tablet, 1000 mcg, 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 LOSARTAN POTASSIUM, Tablet, 50 mg Labeling: Label Mixup: LOSARTAN POTASSIUM, Tablet, 50 mg may have potentially been mislabeled as the following drug: ATORVASTATIN CALCIUM, Tablet, 80 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 AMANTADINE HCL, Tablet, 100 mg Labeling: Label Mixup: AMANTADINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: MAGNESIUM CHLORIDE, Tablet, 64 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 chlorproMAZINE HCl, Tablet, 50 mg Labeling: Label Mixup: chlorproMAZINE HCl, Tablet, 50 mg may have potentially been mislabeled as the following drug: ACAMPROSATE CALCIUM DR, Tablet, 333 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 chlorproMAZINE HCl, Tablet, 100 mg Labeling: Label Mixup: chlorproMAZINE HCl, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: ACYCLOVIR, Tablet, 800 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 VITAMIN B COMPLEX W/C, Tablet, 0 mg, Over The Counter Labeling: Label Mixup: VITAMIN B COMPLEX W/C, Tablet, 0 mg may have potentially been mislabeled as one of the following drugs: MULTIVITAMIN/ MULTIMINERAL/… 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 PYRIDOXINE HCL, Tablet, 50 mg, Over The Counter Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 1 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 ASCORBIC ACID, Tablet, 250 mg, Over The Counter Labeling: Label Mixup: ASCORBIC ACID, Tablet, 250 mg may have potentially been mislabeled as one of the following drugs: PREGABALIN, Capsule, 200 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 ASCORBIC ACID, Tablet, 500 mg, Over The Counter Labeling: Label Mixup: ASCORBIC ACID, Tablet, 500 mg may have potentially been mislabeled as the following drug: VENLAFAXINE HCL, Tablet, 100 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 ASCORBIC ACID, Tablet, 500 mg, Over The Counter Labeling: Label Mixup: ASCORBIC ACID, Tablet, 500 mg may have potentially been mislabeled as the following drug: OXcarbazepine, Tablet, 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 ASCORBIC ACID, CHEW Tablet, 500 mg, Over The Counter Labeling: Label Mixup: ASCORBIC ACID, CHEW Tablet, 500 mg may have potentially been mislabeled as the following drug: PHENOL, LOZENGE, 29 mg, NDC 00068021918,… 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 THIAMINE HCL, Tablet, 100 mg, Over The Counter Labeling: Label Mixup: THIAMINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: SIMVASTATIN, Tablet, 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 NIACIN TR, Capsule, 250 mg Labeling: Label Mixup: NIACIN TR, Capsule, 250 mg may have potentially been mislabeled as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 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 NIACIN TR, Capsule, 500 mg Labeling: Label Mixup: NIACIN TR, Capsule, 500 mg may have potentially been mislabeled as one of the following drugs: PERPHENAZINE, Tablet, 16 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 ASPIRIN EC, Tablet, 325 mg, Over The Counter Labeling: Label Mixup: ASPIRIN EC, Tablet, 325 mg may have potentially been mislabeled as one of the following drugs: MULTIVITAMIN/MULTIMINERAL, CHEW Tablet, 0… 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 TRI-BUFFERED ASPIRIN, Tablet, 325 mg, Over The Counter Labeling: Label Mixup: TRI-BUFFERED ASPIRIN, Tablet, 325 mg may have potentially been mislabeled as the following drug: ISOMETHEPTENE MUCATE/… 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, Tablet, 100 mg, Over The Counter Labeling: Label Mixup: NIACIN, Tablet, 100 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815,… 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, Tablet, 500 mg, Over The Counter Labeling: Label Mixup: NIACIN, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: NAPROXEN, Tablet, 500 mg, NDC 53746019001,… 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 SELENIUM, Tablet, 50 mcg, Over The Counter Labeling: Label Mixup :SELENIUM, Tablet, 50 mcg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815,… 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 HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. Class IIFDA’s classJan 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. Class IIFDA’s classJan 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. Class IIFDA’s classJan 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Propofol Injectible Emulsion, 1%, 200 mg/20 mL Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container. Class IIFDA’s classJan 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall sertraline HCl tablets, 25 mg, 30 Tablets Labeling: Incorrect or Missing Lot No. Class IIFDA’s classJan 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle Failed Stability Specifications: this product is below specification for preservative content. Class IIIFDA’s classJan 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10… 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 Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 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 Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 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 Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets,… 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 Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine… 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 MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 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 Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 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 Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus… 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 Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 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 NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan… 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 NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 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 NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine… 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 NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 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 NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 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
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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.
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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