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 MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack… Subpotent; 6 month stability time point Class IIIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point. Class IIIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles Failed Impurity/Degradation Specification; high out of specification for CAD II degradant Class IIIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles Failed Content Uniformity Specifications. Class IIIFDA’s classSep 24, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 24, 2014ClassClass IIIStatusTerminatedWhereCalifornia, Hawaii, Illinois, Mississippi, New Hampshire, Ohio and Texas
- Medicine recall Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water,… Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in… Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water,… Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in… Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall NORepinephrine 4 mg Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for… Class IIFDA’s classSep 24, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWherePennsylvania, Tennessee and Texas
- Medicine recall Bupivacaine HCl Inj., USP, 0.5% Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Oxcarbazepine Tablets, 300 mg, 100 tablets per carton Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 0.9% Sodium Chloride Injection USP Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag Presence of Particulate Matter: particulate matter identified as fibers and/or plastics FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC,… Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vial Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158,… Marketed Without an Approved NDA/ANDA: Nova Products, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineering Co., Ltd, USA. Marketed Without an Approved NDA/ANDA: Nova Products, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall XZEN GOLD,750 mg, six capsules per bottle Marketed Without an Approved NDA/ANDA: Nova Products, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall XZEN PLATINUM, 750 mg, 1 capsule per blister pack Marketed Without an Approved NDA/ANDA: Nova Products, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Xzen 1200, 750 mg, six capsules per bottle Marketed Without an Approved NDA/ANDA: Nova Products, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Xzone 1200, 750 mg, one capsule per blister pack Marketed Without an Approved NDA/ANDA: Nova Products, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall XZONE GOLD, 750 mg, one capsule blister pack Marketed Without an Approved NDA/ANDA: Nova Products, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall MOJO RISEN ,670 mg, 2 capsule per pouch Marketed Without an Approved NDA/ANDA; Nova Products, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall CHIROTHIN Dietary Supplement, 2 Fl Oz Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG. Class IIIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation,… Lack of Assurance of Sterility; complaints of mold in the overpouch Class IIFDA’s classSep 17, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 17, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. Class IIFDA’s classSep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Famotidine for Oral Suspension, USP 40 mg/5 mL Failed Impurity/Degradation Specification; 12-month stability time point Class IIIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall VIVITROL (naltrexone for extended-release injectable suspension) Customer complaints for failure to deliver the dose. Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. Class IIIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges. Class IIIFDA’s classSep 3, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 3, 2014ClassClass IIIStatusTerminatedWhereArkansas, Illinois, Minnesota, Ohio, Oregon, Pennsylvania and Rhode Island
- Medicine recall PEDIATRIC CARDIOPLEGIA, 255 mL Non Sterility; microbial contamination identified as Aspergillus species FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereMichigan and Wisconsin
- Medicine recall del Nido Cardioplegia with Lidocaine 1052.8 ml Non Sterility; microbial contamination identified as Aspergillus species FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereMichigan and Wisconsin
- Medicine recall adenosine 90 mg Non Sterility; microbial contamination identified as Aspergillus species FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereMichigan and Wisconsin
- Medicine recall LOW Potassium Cardioplegia 792 mL Non Sterility; microbial contamination identified as Aspergillus species FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereMichigan and Wisconsin
- Medicine recall MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereNationwide
Nothing matches all of these.
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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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