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 Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. 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 Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Wellness Pharmacy, L.L.C.,… Lack of assurance of sterility Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110 Lack of assurance of sterility Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Prostaglandin Rx, dispensed Lack of assurance of sterility Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY… Lack of assurance of sterility Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY… Lack of assurance of sterility Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham,… Lack of assurance of sterility Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham,… Lack of assurance of sterility Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY… Lack of assurance of sterility Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL,… Lack of assurance of sterility Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C.,… Lack of assurance of sterility Class IIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMay 20, 2015ClassClass IIStatusTerminatedWhereNew York
- Medicine recall MAGNESIUM SULFATE Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT… Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires… Class IIIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. Class IIIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 20, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister… Subpotent drug Class IIIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count… Subpotent drug Class IIIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle Subpotent drug Class IIIFDA’s classMay 20, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle Failed Dissolution Specification; 6 month time point 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 Phen 15 mg - Topri 92 mg SR Cap (Qsymia), 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 KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle Crystallization Class IIFDA’s classMay 13, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereOklahoma and Pennsylvania
- Medicine recall Captopril Tablets, USP 12.5 mg Failed Tablet/Capsule Specifications: out of specification for thickness. Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, 250 mL Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W,… Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide, and West Virginia named
- Medicine recall iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC… Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide, and West Virginia named
- Medicine recall AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highway 70 W, Suite 227, Garner, NC… Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide, and West Virginia named
- Medicine recall BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529 Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide, and West Virginia named
- Medicine recall iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227,… Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide, and West Virginia named
- Medicine recall Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only, Not for Resale or… Non-Sterility: The recalled lot failed sterility testing. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 13, 2015ClassClass IStatusTerminatedWhereArizona and Kansas
- Medicine recall Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall M1-ALPHA LABS MEGA MASS BUILDER (M1A, Methyl-1-Etiocholenolol- 20mg, Epietiocholanolone) Capsules, 60 count… Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid)… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall M14-MENT ADVANCED MASS BUILDER Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid)… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall HALO-70 MEGA MASS BUILDER Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid)… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 7-MENT ALPHA ADVANCED MASS BUILDER Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid)… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-dione 15mg,… Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid)… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall SWOLL-250 SUPER MASS BUILDER QUAD STACK Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid)… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg:… Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid)… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix… Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74) Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL Class IIFDA’s classMay 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Forever Beautiful INFINITY, capsules, 300mg Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Forever Beautiful BEE POLLEN, capsules, 250mg Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Fluoxetine Capsules USP, 10 mg Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluoxetine Capsules USP, 20 mg Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketorolac Tromethamine Inj Crystallization Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Ketorolac Tromethamine Inj Crystallization Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall 0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit Lack of Sterility Assurance: The product has the potential to leak at the administrative port. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually… Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a… Class IIIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Rose Bengal GloStrips (rose bengal) Ophthalmic Strips USP, 1.3 mg per strip, individually wrapped strip (NDC… Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a… Class IIIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Fluorescein Sodium Ophthalmic Strips USP, 1.0 mg per strip, labeled as 1) FUL-GLO, individually wrapped… Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a… Class IIIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 29, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
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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