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 12,861–12,880 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Glucosamine HCL Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Magnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3298-02

by US Compounding Inc

Reason
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Recall initiated
September 12, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3205-06

by US Compounding Inc

Reason
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Recall initiated
September 12, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3155-01

by US Compounding Inc

Reason
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Recall initiated
September 12, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2171-02

by US Compounding Inc

Reason
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Recall initiated
September 12, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3083-99

by US Compounding Inc

Reason
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Recall initiated
September 12, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3057-06

by US Compounding Inc

Reason
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Recall initiated
September 12, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC: 62295-3253-05.

by US Compounding Inc

Reason
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Recall initiated
September 12, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.

by Par Pharmaceutical Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Recall initiated
October 26, 2015
Reported by FDA
November 25, 2015
Distribution
U.S. Nationwide including Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass I

MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.

by The One Minute Miracle Inc

Reason
Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.
Recall initiated
August 27, 2015
Reported by FDA
November 18, 2015
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354.

by The One Minute Miracle Inc

Reason
Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.
Recall initiated
August 27, 2015
Reported by FDA
November 18, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

TRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

by the Compounder

Reason
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Recall initiated
March 10, 2015
Reported by FDA
November 18, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) (23) 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

by the Compounder

Reason
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Recall initiated
March 10, 2015
Reported by FDA
November 18, 2015
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.