Medicines, 2016
Shortlist up to four to read them side by side.
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 5, 2026.
1,254of 1,254 medicine recallsshown with your filters
The list
- Medicine recall Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton Labeling: Missing Label-Primary packaging label (i.e. Class IIIFDA’s classOct 5, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedOct 5, 2016ClassClass IIIStatusTerminatedWhereColorado, Illinois, Louisiana and Ohio
- Medicine recall PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17. Class IIIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402 Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compounder, Hattiesburg, MS Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/ml, Dexamethasone Sodium… Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402 Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Papaverine 150 mg / Phentolamine 5 mg vials Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402 Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402 Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Moxifloxacin HCl 1 mg/ml Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402 Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402 Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Pre-Op Pledget Soln + Tetracaine, (Tropicamide Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg… Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg… Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402 Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg, MS Lack of Assurance of Sterility Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Lansoprazole Delayed-Release Capsules, USP, 30 mg Labeling: Label mix-up. Class IIIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lisinopril Tablets USP, 30 mg CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. Class IIIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 28, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Lisinopril Tablets USP, 40 mg, 1000-count bottles CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. Class IIIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 28, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13),… Failed Impurities/Degradation Specifications Class IIIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-count bottle (NDC 57664-244-13),… Failed Impurities/Degradation Specifications Class IIIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18) Failed Impurities/Degradation Specifications Class IIIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13),… Failed Impurities/Degradation Specifications Class IIIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereMinnesota
- Medicine recall Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereMinnesota
- Medicine recall Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereMinnesota
- Medicine recall Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereMinnesota
- Medicine recall Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereMinnesota
- Medicine recall Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01) Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Phenylephrine HCI Injection, USP, 10mg/mL Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted) Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed. Class IIIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Escitalopram Tablets USP 20 mg, 100-count bottles Labeling: Incorrect or Missing Lot and/or Expiration Date Class IIIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Mucinex Sinus-Max Day Night, 60 caplets, Dist Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Class IIIFDA’s classSep 28, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 28, 2016ClassClass IIIStatusTerminatedWhereFlorida, Massachusetts and New Jersey
- Medicine recall Mozobil (plerixafor injection) 24 mg/1.2 mL Labeling: Incorrect or Missing Lot and/or Exp. Class IIIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the… Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use Discoloration: Firm received complaints of product discoloration and particulates. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing. Class IIIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 21, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Selegiline HCL Tablets USP 5mg, 60- count bottles Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples. Class IIIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedSep 14, 2016ClassClass IIIStatusTerminatedWhereNorth Carolina
- Medicine recall Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine… Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine… Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 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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