Medicines, 2015
Shortlist up to four to read them side by side.
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 Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point. Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours Defective Delivery System: One lot exceeded the mechanical peel specification Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR… Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing. Class IIIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil are being recalled because they contains Estradiol Valerate 20… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall CYANOCOBALAMIN (PARABEN WATER) Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ESTRADIOL CYPIONATE (SESAME OIL) 10ML, 30ML VIAL 5MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225… Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ESTRADIOL VALERATE Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton… Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GLUTATHIONE 200MG/ML (STERILE WATER) Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GLYCERIN (STERILE WATER) 100ML 71% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North… Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE, Advanced Compounding Pharmacy,… Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROXYZINE HYDROCHLORIDE Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROXYZINE HYDROCHLORIDE (STERILE WATER) Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton… Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compounding Pharmacy, 7225 Fulton Ave., North… Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SODIUM HYALURONATE Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SODIUM HYALURONATE (STERILE WATER) 2.5 ML VIAL 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton… Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave.,… Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SODIUM TETRADECYL SULFATE (STERILE WATER) Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VITAMIN D3 (OLIVE OIL) Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LACTATED RINGER’S IRRIGATION, USP, 3000 mL flexible container bag Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Captopril Tablets, USP, 50 mg, 30 Tablets cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportIndianathe one state its words name PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereIndiana
- Medicine recall Clarithromycin Tablets, USP, 500 mg, 20 Tablets cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted… Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportIndianathe one state its words name PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereIndiana
- Medicine recall DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave.,… Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ESTRADIOL CYPIONATE (SESAME OIL) Lack of Assurance of Sterility Class IIFDA’s classJun 3, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during… Class IIIFDA’s classMay 27, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall ImproVue Ophthalmic Lubricant Drops Failed pH specification Class IIIFDA’s classMay 27, 2015in FDA’s Enforcement ReportFloridathe one state its words name PublishedMay 27, 2015ClassClass IIIStatusTerminatedWhereFlorida
- Medicine recall SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose… Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall HCG 1000 Units/mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Cyanocobalamin 2000mcg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Methylcobalamin 1000 mcg/mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Sodium Tetradecyl 1% Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Laureth-P 1% Injection (Polidocanol), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Trimix #1 (Original) Injection (papaverine 75 mg - phentolamine 2.5 mg - PGE 25 mcg/10 mL), Health Innov… Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Dexamethasone 4 mg/mL Iontophoresis, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Fortifed Tobramycin 15 mg/1 mL Opth., Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Glycerin 98.5% Opth Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall EDTA 3% Eye Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Serum 50% BSS 50% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Phospholine Iodide 0.03% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Progest 200 mg/1 mL Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Testosterone 100 mg/1 mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Estradiol 0.01% Vaginal Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Estriol 5% Cream Vaginal Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Naltrexone 4.5 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387 Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures… Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 20, 2015ClassClass 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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