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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 9,621–9,640 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply.

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply.

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply.

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Xolair 150 mg SDV NDC 50242-0040-62 28 days

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply.

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-0004-15 30 days supply.

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply.

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply.

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Botox 100 Units Vial NDC 00023-1145-01 90 days supply.

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

View recall →

Drug Recall Terminated Historical recordClass II

Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply;

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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.