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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 9821–9840 of 17,793 recalls

Class IITerminated

Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosolized product in a can, NET WT. 5 OZ (141 g) , Distributed by Johnson & Johnson Consumer Inc. Skillman, NJ 08558, UPC 0 70501 11131 4

Johnson & Johnson

Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.

December 7, 2017 · DrugView details →

Class IITerminated

Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped Foam Cleanser) Case Code: 00070501302866

Johnson & Johnson

Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.

December 7, 2017 · DrugView details →

Class IIITerminated

Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10

Sanofi-Aventis U.S. LLC

Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL

December 5, 2017 · DrugView details →

Class IITerminated

Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50

Solco Healtcare US LLC

Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg

December 4, 2017 · DrugView details →

Class ITerminated

Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00

AuroMedics Pharma LLC

Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass

December 4, 2017 · DrugView details →

Class IITerminated

Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10

ALLERGAN

Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.

December 4, 2017 · DrugView details →

Class IIITerminated

Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba Nutra Labs, Inc., Palmetto, FL

BYL Solutions Inc.

Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil

November 30, 2017 · DrugView details →

Class IITerminated

All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.

Intrathecal Compounding Specialist, LLC

Lack of sterility assurance.

November 30, 2017 · DrugView details →

Class IITerminated

All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.

Intrathecal Compounding Specialist, LLC

Lack of sterility assurance.

November 30, 2017 · DrugView details →

Class IITerminated

All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.

Intrathecal Compounding Specialist, LLC

Lack of sterility assurance.

November 30, 2017 · DrugView details →

Class IITerminated

All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.

Intrathecal Compounding Specialist, LLC

Lack of sterility assurance.

November 30, 2017 · DrugView details →

Class IITerminated

Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09.

Prinston Pharmaceutical Inc

Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.

November 29, 2017 · DrugView details →

Class ITerminated

BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5

Blue Fusion Natural

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.

November 29, 2017 · DrugView details →

Class IIITerminated

Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.

November 28, 2017 · DrugView details →

Class IITerminated

Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0.

EAI-JR286 INC

CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.

November 28, 2017 · DrugView details →

Class IIITerminated

Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068

Lupin Pharmaceuticals Inc.

Failed Dissolution Specification

November 21, 2017 · DrugView details →

Class IITerminated

Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: Market complaints related to "gritty texture".

November 20, 2017 · DrugView details →

Class IITerminated

Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534

Zydus Pharmaceuticals USA Inc

Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets

November 20, 2017 · DrugView details →

Class IITerminated

Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28

Teva Pharmaceuticals USA

Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.

November 20, 2017 · DrugView details →

Class ITerminated

Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA

www.blankterrmall.com

Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.

November 19, 2017 · DrugView details →

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