Skip to main content

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 10,041–10,060 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass I

Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass I

YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass I

HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass II

MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass II

STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass I

Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass I

ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass II

Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass I

Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass I

GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass I

LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass II

HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass I

GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass I

GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass I

Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass III

Indian God Lotion Spray Bottle, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass II

Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language

by A&H Focal Inc.

Reason
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated
March 7, 2017
Reported by FDA
February 7, 2018
Distribution
NY and NJ through six retail stores named "Asian Food Markets"

View recall →

Drug Recall Terminated Historical recordClass I

Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16

by International Laboratories, LLC

Reason
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Recall initiated
January 4, 2018
Reported by FDA
February 7, 2018
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass III

Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10

by Fresenius Kabi USA, LLC

Reason
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Recall initiated
January 16, 2018
Reported by FDA
February 7, 2018
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Recall initiated
January 29, 2018
Reported by FDA
February 7, 2018
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.