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 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser. Class IIIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg… Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. Class IIIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled… Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled… Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled… Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit with prefilled… Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled… Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide Class IIIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Children’s Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide Class IIIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Children’s Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape… Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution. Class IIIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Risperidone Oral Solution, 1 mg/mL, 30 mL bottle Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point. Class IIIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class IIIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class IIIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class IIIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class IIIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class IIIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class IIIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class IIIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and… Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class IIIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class IIIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg… Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. Class IIIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall RezzRX capsules, Single Blister Pack and 20 count bottle Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 30, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a… Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 30, 2014in FDA’s Enforcement ReportWisconsinthe one state its words name PublishedApr 30, 2014ClassClass IStatusTerminatedWhereWisconsin
- Medicine recall Tikosyn¿ (dofetilide) 500 mcg Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg). Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6,… Subpotent Drug: Phenylephrine component is subpotent. Class IIIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Oxandrolone Tablets, USP, 10 mg Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. Class IIIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg ,… Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10… Class IIFDA’s classApr 30, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereCalifornia, Ohio, Pennsylvania, Rhode Island and Texas
- Medicine recall Potassium Chloride for Inj Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Slim Fortune capsules Dietary Supplement Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Lidiy capsules Dietary Supplement Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Slim Expert softgel capsules Dietary Supplement Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 1% Lidocaine HCl Injection, USP, 10 mg/mL Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Prolifta Dietary Supplement Prolifta, 400mg/capsule Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Virilis Pro, 450mg/capsule Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only Penicillin Cross Contamination Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only Penicillin Cross Contamination Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant… Penicillin Cross Contamination Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only Penicillin Cross Contamination Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only Penicillin Cross Contamination Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only Penicillin Cross Contamination Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only Penicillin Cross Contamination Class IIFDA’s classApr 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 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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