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 SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz. Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm’s routine testing. Class IIIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 2, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz. Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm’s routine testing. Class IIIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 2, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm’s routine testing. Class IIIFDA’s classApr 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 2, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clinimix 4.25/25 sulfite-free Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Clinimix E 4.25/10 sulfite-free Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Clinimix 5/15 sulfite-free Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 0.9% Sodium Chloride Injection, USP Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping Class IIFDA’s classMar 26, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereMaryland and Virginia
- Medicine recall Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison,… Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate. Class IIIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval. Class IIIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language) Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Silver Sword capsules, 180 mg, 16-count clamshell tin Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Triamcinolone Acetonide Cream USP, 0.1% Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%. Class IIIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Alprazolam 1 mg Tablets, USP, 500 count Bottle Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bottle Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making it an unapproved new drug. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets Failed Impurity/degradation Specification Class IIIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 19, 2014in FDA’s Enforcement ReportMichiganthe one state its words name PublishedMar 19, 2014ClassClass IStatusTerminatedWhereMichigan
- Medicine recall Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014. Class IIIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle Failed Dissolution Specifications: Product did not meet specification requirements for dissolution. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate… CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg,… Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating… Class IIIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine 4% Urethral Gel Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Acetylcysteine 10% ophthalmic Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall AMP/M-B12/Pyridox/Methionine Inositol Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Bladder Instillation Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Bleomycin Sulfate 1unit/ml Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Cyanocobalamin 100mcg/ml injection Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Cyano B-12 p-f 1000mcg/ml Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Cyano B-12 (Cmpd) 1000mcg/ml Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Dexamethasone (pf) 0.05 % opth. Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Dexamethasone phosphate 24mg/ml inj. Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Ethanol 20% ophthal. Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall EDTA 3% ophthalmic Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall 5-Fluorouracil pf in methocel 1% opthal Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall 5-Fluorouracil 1% ophthal Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Folic acid (pf) 10mg/cc inj Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
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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