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 SlimEasy Herbs Capsule, 400 mg, supplied Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Meizi Evolution Soft Gel Capsules, supplied Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Slim Xtreme Weight loss capsules, 500 mg, supplied Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Magic Slim capsules, supplied Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Meizitang Strong Version Botanical Slimming, Soft Gel Capsules, 650 mg, supplied Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Dr. Reddy’s Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured… Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CUBICIN (daptomycin for injection), 500 mg single-use vial Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 18, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted Defective Container: Tamper evident ring failures discovered on some bottles. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand… Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand… Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. Class IIFDA’s classJun 11, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 11, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles Presence of Foreign Substance: Presence of stainless steel particles. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Burn 7 Capsules, supplied Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 4, 2014in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJun 4, 2014ClassClass IStatusTerminatedWherePuerto Rico
- Medicine recall PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4… Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution Class IIIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and… Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution Class IIIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a… Non-sterility: due to a failed sterility test Class IIFDA’s classJun 4, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereKentucky and New York
- Medicine recall Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle Failed Dissolution Specifications: Failure of dissolution test observed at three month time point. Class IIFDA’s classJun 4, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Acetylcysteine Solution, USP, 10%, 30 mL vial Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 28, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico… Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plastic zip-lock pouch Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herbal Give Care, Av… Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottle Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle, Hecho en Mexico: Soluciones HGC… Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall XZONE GOLD, 1 capsule blister 750 mg Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Nevada, New York, Pennsylvania, Texas and Wisconsin
- Medicine recall BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Nevada, New York, Pennsylvania, Texas and Wisconsin
- Medicine recall SEXY MONKEY, 2000 mg, 1 count blister Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Nevada, New York, Pennsylvania, Texas and Wisconsin
- Medicine recall MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Nevada, New York, Pennsylvania, Texas and Wisconsin
- Medicine recall Magic For Men Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Nevada, New York, Pennsylvania, Texas and Wisconsin
- Medicine recall ExtenZe 600 mg, 30 tablet box Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Nevada, New York, Pennsylvania, Texas and Wisconsin
- Medicine recall XZEN PLATINUM, 750 mg Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Nevada, New York, Pennsylvania, Texas and Wisconsin
- Medicine recall QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered… Defective Delivery System; defective valve Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMay 28, 2014ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Liothyronine Sodium Tablets, USP 5 mcg Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of… Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall P-BOOST Capsules Dietary Supplement 500 mg, supplied Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall NATURECT Capsules Dietary Supplement 500 mg, supplied Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl Labeling: Missing Label; The label on the immediate bottle is missing. Class IIIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout… Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Red Yeast Rice High Potency Dietary Supplement, 600 mg Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Class IIFDA’s classMay 28, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 28, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Class IIFDA’s classMay 21, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall INDOMETHACIN Capsules USP, 25 mg 100 count bottle CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Class IIFDA’s classMay 21, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC… CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements. Class IIFDA’s classMay 21, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 21, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate. Class IIIFDA’s classMay 21, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedMay 21, 2014ClassClass IIIStatusTerminatedWhereFlorida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina and Texas
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.
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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