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 5, 2026.
1,562of 1,562 medicine recallsshown with your filters
The list
- Medicine recall Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP… Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe Marketed without an Approved NDA/ANDA. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 50 mg Nitroglycerin Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles Failed Dissolution Specification; 8 hr stability timepoint Class IIIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval Class IIIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg Failed Tablet/Capsule Specifications: Broken tablets Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CHILDREN’S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY… CGMP Deviation: Discoloration; Product fails specification for appearance/color. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereGeorgia, Kentucky and Tennessee
- Medicine recall Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. Class IIIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Namenda XR (memantine HCl), titration pack Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. Class IIIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. Class IIIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry. Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes… Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HEALTH & BEYOND DR Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic) Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Hawaii, Illinois, New York, Pennsylvania and Washington
- Medicine recall Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50) Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with… Class IIIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11) Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with… Class IIIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50) Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with… Class IIIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10) Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with… Class IIIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50) Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with… Class IIIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-10) Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with… Class IIIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Hydralazine HCL Tablets, USP, 25 mg in a single blister package Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydralazine HCL Tablets, USP, 50 mg in a single blister package Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC… Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FAMILY wellness Triple Antibiotic Ointment Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dollar General Triple Antibiotic Ointment Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle Failed Dissolution Specification: Corepharma Inc. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dr. Reddy’s Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy’s… Failed Dissolution Specification; 12-Month stability interval. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereLouisiana, Michigan, Missouri, Mississippi and Ohio
- Medicine recall Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with… Lack of Assurance of Sterility; potential leakage from administrative port. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Heparin Sodium 2000 USP Heparin Units per 1000 mL Lack of Assurance of Sterility; potential leakage from administrative port. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant, Redness Reliever… Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months. Class IIIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall KETOCONAZOLE CREAM, 2%, 30 gram tube Failed Impurities/Degradation Specifications: Out-of-Specification degradant results. Class IIIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 5, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 5, 2014ClassClass IStatusTerminatedWhereCalifornia
- Medicine recall MaXtremeZEN capsules, 1 capsule per blister pack Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 5, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 5, 2014ClassClass IStatusTerminatedWhereCalifornia
- Medicine recall eXtenZone capsules, 1 capsule per blister pack Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 5, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 5, 2014ClassClass IStatusTerminatedWhereCalifornia
- Medicine recall Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor… Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL Presence of Particulate Matter: Failed the appearance test for the presence of visible particles. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary… Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 5, 2014ClassClass IStatusTerminatedWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244 Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244 Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles Failed Tablet/Capsule Specifications; Product contains broken tablets. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina and Wisconsin
- Medicine recall ISOSORBIDE DINITRATE, Tablet, 10 mg Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: SODIUM CHLORIDE, Tablet, 1 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 ISOSORBIDE DINITRATE, Tablet, 5 mg Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: CILOSTAZOL, 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 IMIPRAMINE HCL, Tablet, 25 mg Labeling: Label Mixup: IMIPRAMINE HCL, Tablet, 25 mg may have potentially been mislabeled as the following drug: FENOFIBRATE, Tablet, 54 mg, NDC 00115551110,… 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.
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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