Medicines, 2015
Shortlist up to four to read them side by side.
2,020 medicine recalls FDA’s Enforcement Report published in 2015, 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.
2,020of 2,020 medicine recallsshown with your filters
The list
- Medicine recall HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001… Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cetirizine HCl 10 mg Tablet, 14 count blister packs Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester Class IIIFDA’s classDec 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 30, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles Labeling: Incorrect or Missing Lot AND/OR Exp Date. Class IIIFDA’s classDec 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg Failed Impurities/Degradation Specifications: Out of specification for impurities. Class IIIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall MECLIZINE HYDROCHLORIDE TABLETS, 25 mg Failed Impurities/Degradation Specifications: Out of specification for impurities. Class IIIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis Labeling: Incorrect Instructions; RemedyRepack, Inc. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma Inc., Bristol, TN 37620,… Labeling: Incorrect Instructions; RemedyRepack, Inc. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103,… Labeling: Incorrect Instructions; RemedyRepack, Inc. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged… Labeling: Incorrect Instructions; RemedyRepack, Inc. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724, Repackaged by:… Labeling: Incorrect Instructions; RemedyRepack, Inc. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-2880,… Labeling: Incorrect Instructions; RemedyRepack, Inc. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103,… Labeling: Incorrect Instructions; RemedyRepack, Inc. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one… Class IIFDA’s classDec 16, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereFlorida, Missouri and Tennessee
- Medicine recall Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life. Class IIFDA’s classDec 16, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 16, 2015ClassClass IIStatusTerminatedWhereMississippi and Vermont
- Medicine recall Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg Failed Dissolution Specification Class IIIFDA’s classDec 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10… Discoloration Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg), 30… Discoloration Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Carbo-O-Philic 40 Gel 40% (Urea) Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Ace-Promazine 10 mg/mL Injection, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall AMP50/B121MG Complex Mix/ML Injection, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall B-12 1000/B6 1000 mcg/mL Injection, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Bladder Mixture Prep, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Boric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Butor/Nal/Hydro Nasal Susp, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Cyclosporine 1% Opth Sol, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Dep-Estradiol 10 mg/mL Injection, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Depo-Testadiol 10/5mg/mL Injection, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Folic Acid Injection 5 mg/mL,10 mg/mL, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Furosemide 20 mg/mL svn Sol, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Gent 80 mg/Liter Nasal, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Glutathione 200 mg/mL SVN Injection, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Glutathione 300 mg/1.5 mL Injection, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Hydroxocobalamin 1mg/mL Injection, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall M-Cobalamin (B12) Injection 200 mcg, 2000mcg, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall M-Cobalamin 2/Folate 5mg/mL Injection, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Medroxyprogesterone 150/LID 5 mg/mL Injection, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Methylcobalamin Injection 1000 mcg/mL, 10000 mcg/mL, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Methylcobalamin Injection 10 mg/mL, 20 mg/mL, 30 mg/mL, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Mupiro/Doxycyc Sinus Rinse, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Alcohol4%/Bupivicaine0.5% sol, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
- Medicine recall Ascorbic Acid 500 mg/mL Injection, Rx, Western Drug Inc. 106 E Lack of Assurance of Sterility Class IIFDA’s classDec 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas and Utah named
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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