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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 7,121–7,140 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

by Innoveix Pharmaceuticals Inc

Reason
Lack of Sterility Assurance.
Recall initiated
October 10, 2019
Reported by FDA
November 6, 2019
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

by Innoveix Pharmaceuticals Inc

Reason
Lack of Sterility Assurance.
Recall initiated
October 10, 2019
Reported by FDA
November 6, 2019
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass I

Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia, LTDA. Pasaje Luis Tola 9A Y Calle Juan Campuzano, Sector Carcelen, Quito-Ecuador 170302 Distributed By: Fitoterapia USA Inc., 500 NW 141 Ave. 112 Pembroke Pines, FL 33028

by FITOTERAPIA USA, INC

Reason
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Recall initiated
September 16, 2019
Reported by FDA
November 6, 2019
Distribution
FL, PA, NY and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Recall initiated
September 27, 2019
Reported by FDA
November 6, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Recall initiated
September 27, 2019
Reported by FDA
November 6, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-9

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Recall initiated
September 27, 2019
Reported by FDA
November 6, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-8

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Recall initiated
September 27, 2019
Reported by FDA
November 6, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328. NDC 52536-625-01

by Arbor Pharmaceuticals Inc.

Reason
Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials
Recall initiated
September 27, 2019
Reported by FDA
November 6, 2019
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

by AVKARE Inc.

Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall initiated
October 17, 2019
Reported by FDA
November 6, 2019
Distribution
CO, MO

View recall →

Drug Recall Terminated Historical recordClass II

AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

by AVKARE Inc.

Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recall initiated
October 17, 2019
Reported by FDA
November 6, 2019
Distribution
CO, MO

View recall →

Drug Recall Terminated Historical recordClass III

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.

by Sandoz Inc

Reason
Labeling: Incorrect or missing package insert.
Recall initiated
October 17, 2019
Reported by FDA
November 6, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass III

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06

by Sandoz Inc

Reason
Labeling: Incorrect or missing package insert.
Recall initiated
October 17, 2019
Reported by FDA
November 6, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass III

Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.

by Sandoz Inc

Reason
Labeling: Incorrect or missing package insert.
Recall initiated
October 17, 2019
Reported by FDA
November 6, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

by Innoveix Pharmaceuticals Inc

Reason
Lack of Sterility Assurance.
Recall initiated
October 10, 2019
Reported by FDA
November 6, 2019
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.

by Glenmark Pharmaceuticals Inc., USA

Reason
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Recall initiated
October 22, 2019
Reported by FDA
November 6, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93

by Mylan Pharmaceuticals Inc.

Reason
Failed Dissolution Specification: Low out of specification dissolution results.
Recall initiated
October 18, 2019
Reported by FDA
November 6, 2019
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10.

by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

Reason
Incorrect labeling: Incorrect or missing lot and/or exp date
Recall initiated
October 21, 2019
Reported by FDA
November 6, 2019
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8

by Apotex Inc.

Reason
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Recall initiated
October 22, 2019
Reported by FDA
November 6, 2019
Distribution
IL, MS, NJ, OH, TX

View recall →

Drug Recall Terminated Historical recordClass II

Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20

by Avella of Deer Valley, Inc. Store 38

Reason
Lack of sterility assurance.
Recall initiated
September 18, 2019
Reported by FDA
October 30, 2019
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10

by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

Reason
Lack of Assurance of Sterility; bags have potential to leak
Recall initiated
October 9, 2019
Reported by FDA
October 30, 2019
Distribution
Nationwide.

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.