Medicines, 2015
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2,020 medicine recalls FDA’s Enforcement Report published in 2015, 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 6, 2026.
2,020of 2,020 medicine recallsshown with your filters
The list
- Medicine recall Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Zonisamide Capsules, 50 mg Capsules CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Zonisamide Capsules, 25 mg Capsules CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Captopril Tablets, USP, 25 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Captopril Tablets, USP, 50 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Captopril Tablets, USP, 100 mg Tablets CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton Failed dissolution specifications Class IIIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Rifampin for Injection, USP 600mg/vial in a 20mL vial Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Desmopressin Acetate Tablets, 0.1 mg Tablets Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. Class IIIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nitroglycerin Transdermal System 0.2 mg/hr Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Nitroglycerin Transdermal System 0.4 mg/hr Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Carb-O-Philic 40 Cream, 40%, a) 3 oz CGMP Deviation: Poor container closure of the bulk storage container Class IIIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall HydrOXYzine Hydrochloride Tablets, USP 25 mg Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable Class IIIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit Lack of assurance of sterility: Potential channel leaks near the threaded vial port. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall KETOROLAC Tromethamine Inj., USP, 30 mg Crystallization; identified as calcium salt of Ketorolac Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 22, 2015ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medicine recall KETOROLAC Tromethamine Inj., USP, 60 mg Crystallization; identified as calcium salt of Ketorolac Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 22, 2015ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall SLIM-K, 30 Capsules, barcode 160126417509 Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 15, 2015ClassClass IStatusTerminatedWherePuerto Rico
- Medicine recall 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 15, 2015ClassClass IStatusTerminatedWherePuerto Rico
- Medicine recall 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 15, 2015ClassClass IStatusTerminatedWherePuerto Rico
- Medicine recall Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 15, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 15, 2015ClassClass IStatusTerminatedWherePuerto Rico
- Medicine recall Losartan potassium tablets USP, 25 mg, 90- count bottle Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Losartan potassium tablets USP, 100 mg, 90-count bottle Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Losartan potassium tablets USP, 50 mg, 90-count bottle Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Bupivacaine Hydrochloride Inj., USP, 0.5% Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 15, 2015ClassClass IStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Capecitabine Tablets, USP, 500 mg, 120-count bottle Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine besylate tablets, USP 2.5mg CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine besylate tablets, USP 5mg CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine besylate tablets, USP 10 mg CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Azithromycin tablets, USP 500mg CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Azithromycin tablets, USP 600mg CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Azithromycin tablets, USP 250mg CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clarithromycin tablets, USP 500mg CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Famotidine tablets, USP 20mg CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lisinopril tablets, USP 5mg CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lisinopril tablets, USP 10mg CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lisinopril tablets, USP 20mg CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lisinopril tablets, USP 40mg CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zonisamide capsules, USP 100mg CGMP Deviations: Firm did not adequately investigate customer complaints. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CORTISOL-MC, 10mg CAP Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications. Class IIIFDA’s classJul 15, 2015in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 15, 2015ClassClass IIIStatusTerminatedWhereTexas
- Medicine recall Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use Failed pH Specifications: 12 month stability testing Class IIIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness,… Subpotent Drug: menthol and methyl salicylate below specification Class IIIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIIStatusTerminatedWhereNationwide
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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