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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 7,081–7,100 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, Red Mountain Compounding RX.

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compounding RX.

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

S-ATROPINE 0.02% OPTHALMIC SOLUTION, 10 ML dropper bottle, RX only, Red Mountain Compounding RX

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

S-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN), packaged in a) 50ML, b) 5ML, c) 30ML, glass vial, RX Only, Red Mountain Compounding RX.

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

by Basic Reset Inc.

Reason
Marketed without an Approved NDA/ANDA
Recall initiated
October 18, 2019
Reported by FDA
November 13, 2019
Distribution
United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

View recall →

Drug Recall Terminated Historical recordClass II

BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle, 2400 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

by Basic Reset Inc.

Reason
Marketed without an Approved NDA/ANDA
Recall initiated
October 18, 2019
Reported by FDA
November 13, 2019
Distribution
United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

View recall →

Drug Recall Terminated Historical recordClass II

BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

by Basic Reset Inc.

Reason
Marketed without an Approved NDA/ANDA
Recall initiated
October 18, 2019
Reported by FDA
November 13, 2019
Distribution
United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

View recall →

Drug Recall Terminated Historical recordClass II

Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

by Basic Reset Inc.

Reason
Marketed without an Approved NDA/ANDA
Recall initiated
October 18, 2019
Reported by FDA
November 13, 2019
Distribution
United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

View recall →

Drug Recall Terminated Historical recordClass II

Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

by Basic Reset Inc.

Reason
Marketed without an Approved NDA/ANDA
Recall initiated
October 18, 2019
Reported by FDA
November 13, 2019
Distribution
United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

View recall →

Drug Recall Terminated Historical recordClass II

Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

by Basic Reset Inc.

Reason
Marketed without an Approved NDA/ANDA
Recall initiated
October 18, 2019
Reported by FDA
November 13, 2019
Distribution
United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

View recall →

Drug Recall Terminated Historical recordClass II

Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

by Basic Reset Inc.

Reason
Marketed without an Approved NDA/ANDA
Recall initiated
October 18, 2019
Reported by FDA
November 13, 2019
Distribution
United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

View recall →

Drug Recall Terminated Historical recordClass II

Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA exclusively for Basic Reset 260 W. Main St., Ste 103 Hendersonville, TN 37075

by Basic Reset Inc.

Reason
Marketed without an Approved NDA/ANDA
Recall initiated
October 18, 2019
Reported by FDA
November 13, 2019
Distribution
United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

View recall →

Drug Recall Terminated Historical recordClass II

Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075

by Basic Reset Inc.

Reason
Marketed without an Approved NDA/ANDA
Recall initiated
October 18, 2019
Reported by FDA
November 13, 2019
Distribution
United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

View recall →

Drug Recall Terminated Historical recordClass II

Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, Kim Kaufman Productions Nashville, TN.

by Basic Reset Inc.

Reason
Marketed without an Approved NDA/ANDA
Recall initiated
October 18, 2019
Reported by FDA
November 13, 2019
Distribution
United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

View recall →

Drug Recall Terminated Historical recordClass II

Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle, Distributed by: Basic Reset Hendersonville, TN 37075.

by Basic Reset Inc.

Reason
Marketed without an Approved NDA/ANDA
Recall initiated
October 18, 2019
Reported by FDA
November 13, 2019
Distribution
United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

View recall →

Drug Recall Terminated Historical recordClass II

Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05

by Mylan Pharmaceuticals Inc.

Reason
Presence of Foreign Substance
Recall initiated
October 23, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide within the United States

View recall →

Drug Recall Completed Historical recordClass II

Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

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.