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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 8,721–8,740 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide Dexpanthenol/Pyridoxine/Methylcobalamin/Leucine/Chromium 25 mg/50 mg/50 mg/25 mg/2.5 mg/25 mg/2 mg/25 mg/0.5 mg2.5 mg/1.33 mcg/mL injection 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists, 31818 US Hwy 19N, Palm Harbor FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.

by Promise Pharmacy, LLC

Reason
Lack of sterility assurance.
Recall initiated
December 17, 2018
Reported by FDA
February 20, 2019
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass I

the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry (fruit) Lactase, Tribulus Terrestris Extract, Piperine), 10 count mylar package, Nature's Rx, Claremont, CA

by Natures Rx

Reason
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Recall initiated
January 25, 2019
Reported by FDA
February 13, 2019
Distribution
eBay sales

View recall →

Drug Recall Terminated Historical recordClass III

Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Recall initiated
January 28, 2019
Reported by FDA
February 13, 2019
Distribution
Nationwide within the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.

by US Pharmaceuticals Inc.

Reason
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Recall initiated
December 7, 2018
Reported by FDA
February 13, 2019
Distribution
Nationwide within the United States

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.