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 All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX Lack of Assurance of Sterility Class IIFDA’s classSep 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam HCl 2 mg/ml Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereIllinois, Indiana, Maryland and Texas
- Medicine recall Midazolam HCl 1 mg/ml Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereIllinois, Indiana, Maryland and Texas
- Medicine recall Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class IIFDA’s classSep 3, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 3, 2014ClassClass IIStatusTerminatedWhereIllinois, Indiana, Maryland and Texas
- Medicine recall Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 3, 2014ClassClass IStatusTerminatedWhereIllinois, Indiana, Maryland and Texas
- Medicine recall Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities. Class IIIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 27, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02),… Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and… Class IIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Triveen - PRx RNF Capsules, 30-count bottles Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the… Class IIIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used… Class IIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 27, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 27, 2014ClassClass IStatusTerminatedWhereNew Jersey, New York and Puerto Rico
- Medicine recall Propofol Injectable Emulsion, 1%, 200 mg/20 mL Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall ePHEDrine Sulfate Injection, USP 25 mg/5 mL Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25… Class IIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Doctor’s Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation,… Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 27, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 1500 mcg/30 mL Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereGeorgia and Texas
- Medicine recall fentaNYL 2500 mcg/250 mL Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereGeorgia and Texas
- Medicine recall fentaNYL 200 mcg/100 mL Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereGeorgia and Texas
- Medicine recall fentaNYL 2750 mcg/55 mL Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereGeorgia and Texas
- Medicine recall fentaNYL 5000 mcg/250 mL Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. Class IIFDA’s classAug 27, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 27, 2014ClassClass IIStatusTerminatedWhereGeorgia and Texas
- Medicine recall Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat… Marketed Without an Approved NDA/ANDA: Bacai, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 20, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2014ClassClass IStatusTerminatedWhereNo state named
- Medicine recall Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall E-Z-HD (barium sulfate) For Suspension Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months. Class IIIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 20, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. Class IIIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cephalexin Capsules, USP, 250 mg CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Cephalexin Capsules, USP, 500 mg CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Soliris (eculizumab), 300 mg/30 mL Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 13, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed. Class IIIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Risperdal CONSTA (risperiDONE), 25 mg Dose Pack Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets Presence of Foreign Substance; tablets may contain stainless steel metal particulates Class IIFDA’s classAug 13, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereColorado and Ohio
- Medicine recall Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers. Class IIIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Tetrahydrozoline HCL, 16 kg drum CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Alcohol-Free Hand Sanitizer, 1 Microbial Contamination of Non-Sterile Product Class IIFDA’s classAug 13, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereKentucky, Maryland and Virginia
- Medicine recall Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple… Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lipo 8 Injection USP 200 mg/ml Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass 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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