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 12,841–12,860 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02

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

Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07

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

Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3049-03

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

Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3019-07

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

Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3254-05

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 II

Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3016-02

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

Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3240-07

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

Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-02

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

Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10

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

ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032.

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 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.

by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Reason
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Recall initiated
November 2, 2015
Reported by FDA
November 25, 2015
Distribution
US Nationwide including Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), 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 Terminated Historical recordClass II

HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93.

by Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Reason
Presence of Particulate Matter.
Recall initiated
October 7, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.

by Akorn, Inc.

Reason
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Recall initiated
August 20, 2015
Reported by FDA
November 25, 2015
Distribution
US: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 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

Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 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

Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 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

Progesterone 100 mg/mL in Corn Oil Injection, 2 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

Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 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

MIC Injection, 30 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 →

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.