Medicines, 2016
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1,254 medicine recalls FDA’s Enforcement Report published in 2016, 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.
1,254of 1,254 medicine recallsshown with your filters
The list
- Medicine recall Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle Labeling: Incorrect or Missing Lot and/or Exp. Class IIIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton Labeling: Incorrect or Missing Lot and/or Exp Date Class IIIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton Labeling: Incorrect or Missing Lot and/or Exp Date Class IIIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles,… Defective Delivery System: Product may contain leaking capsules. Class IIIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials Superpotent Drug: one ingredient was found to be above assay specification. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials Lack of Assurance of Sterility: incomplete or missing data regarding production. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial Lack of Assurance of Sterility: incomplete or missing data regarding production. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials Lack of Assurance of Sterility: incomplete or missing data regarding production. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech… Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing. Class IIIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 13, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons Failed Dissolution Specifications Class IIIFDA’s classApr 13, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 13, 2016ClassClass IIIStatusTerminatedWhereFlorida, Louisiana, Michigan, Mississippi, North Carolina, New Jersey, Ohio and South Carolina
- Medicine recall Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot… Class IIIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 13, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Kentucky named
- Medicine recall SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL Labeling: Label Error on Declared Strength Class IIIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate… Failed Impurities/Degradation Specifications: Out of specification for impurities. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate… Failed Impurities/Degradation Specifications: Out of specification for impurities. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate… Failed Impurities/Degradation Specifications: Out of specification for impurities. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate… Failed Impurities/Degradation Specifications: Out of specification for impurities. Class IIFDA’s classApr 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall UN1002 Air, Compressed, Breathing Grade, USP CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. Class IIIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 6, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall UN1002 Air, Compressed, Medical Air, USP CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air. Class IIIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 6, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Zoledronic Acid Injection, 5 mg/100 mL Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape,… Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml. Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Cefazolin 50 mg/mL Ophth Solution, 10mL bottle Lack of Assurance of Sterility Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Edetate Disodium 3% Ophth Solution, 10mL bottle Lack of Assurance of Sterility Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Lidocaine Nebulizer 2% Solution Lack of Assurance of Sterility Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Rose Bengal 1% Ophth Solution, 5mL bottle Lack of Assurance of Sterility Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Silver Nitrate 1% Ophth Solution, 5mL bottle Lack of Assurance of Sterility Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Tobramycin 15mg/mL Ophth Solution Lack of Assurance of Sterility Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Vancomycin 25mg/mL Solution, 10 mL bottles Lack of Assurance of Sterility Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Atropine 0.01% Ophth Solution, 15mL bottle Lack of Assurance of Sterility Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Acetylcysteine 10% Ophth Solution, 10mL bottle Lack of Assurance of Sterility Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Edetate Disodium 2% Ophth Solution, 15mL bottle Lack of Assurance of Sterility Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Lidocaine Nebulizer 1% Solution Lack of Assurance of Sterility Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Vancomycin 50mg/mL Solution, 10mL bottle Lack of Assurance of Sterility Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Tobramycin 14 mg/mL Ophth Solution, 10mL bottle Lack of Assurance of Sterility Class IIFDA’s classApr 6, 2016in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 6, 2016ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only Labeling: Incorrect or Missing Lot and/or Exp Date Class IIIFDA’s classApr 6, 2016in FDA’s Enforcement ReportTennesseethe one state its words name PublishedApr 6, 2016ClassClass IIIStatusTerminatedWhereTennessee
- Medicine recall Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz Labeling: Label Mix-Up Class IIIFDA’s classApr 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 6, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH cGMP Deviations; trailer may not have met GMP requirements prior to filling Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportOhiothe one state its words name PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereOhio
- Medicine recall Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag Cross contamination with other products: metronidazole Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler Defective Delivery System: Some units have actuation counters set to a number other than 60. Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles. Class IIIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 23, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Class IIIFDA’s classMar 23, 2016in FDA’s Enforcement ReportMichiganthe one state its words name PublishedMar 23, 2016ClassClass IIIStatusTerminatedWhereMichigan
- Medicine recall Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders) CGMP Deviations: Cylinders filled using out of date gauges. Class IIIFDA’s classMar 23, 2016in FDA’s Enforcement ReportOklahomathe one state its words name PublishedMar 23, 2016ClassClass IIIStatusTerminatedWhereOklahoma
- Medicine recall NORepinephrine Bitartrate, 4 mg Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration Class IIIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall NORepinephrine Bitartrate, 8 mg Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration Class IIIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe Lack of Assurance of Sterility Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass 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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