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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 14,641–14,660 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Recall initiated
October 14, 2014
Reported by FDA
December 3, 2014
Distribution
Nationwide, Puerto Rico, and U.S. Virgin Islands.

View recall →

Drug Recall Terminated Historical recordClass II

0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Recall initiated
October 14, 2014
Reported by FDA
December 3, 2014
Distribution
Nationwide, Puerto Rico, and U.S. Virgin Islands.

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Recall initiated
October 14, 2014
Reported by FDA
December 3, 2014
Distribution
Nationwide, Puerto Rico, and U.S. Virgin Islands.

View recall →

Drug Recall Terminated Historical recordClass II

Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7967-09.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Recall initiated
October 14, 2014
Reported by FDA
December 3, 2014
Distribution
Nationwide, Puerto Rico, and U.S. Virgin Islands.

View recall →

Drug Recall Terminated Historical recordClass II

Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7953-09.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Recall initiated
October 14, 2014
Reported by FDA
December 3, 2014
Distribution
Nationwide, Puerto Rico, and U.S. Virgin Islands.

View recall →

Drug Recall Terminated Historical recordClass II

5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7941-09.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Recall initiated
October 14, 2014
Reported by FDA
December 3, 2014
Distribution
Nationwide, Puerto Rico, and U.S. Virgin Islands.

View recall →

Drug Recall Terminated Historical recordClass II

Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7929-09.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Recall initiated
October 14, 2014
Reported by FDA
December 3, 2014
Distribution
Nationwide, Puerto Rico, and U.S. Virgin Islands.

View recall →

Drug Recall Terminated Historical recordClass II

5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-09.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Recall initiated
October 14, 2014
Reported by FDA
December 3, 2014
Distribution
Nationwide, Puerto Rico, and U.S. Virgin Islands.

View recall →

Drug Recall Terminated Historical recordClass II

5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7922-09.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Recall initiated
October 14, 2014
Reported by FDA
December 3, 2014
Distribution
Nationwide, Puerto Rico, and U.S. Virgin Islands.

View recall →

Drug Recall Terminated Historical recordClass II

Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Recall initiated
October 14, 2014
Reported by FDA
December 3, 2014
Distribution
Nationwide, Puerto Rico, and U.S. Virgin Islands.

View recall →

Drug Recall Terminated Historical recordClass II

Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7670-09.

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Recall initiated
October 14, 2014
Reported by FDA
December 3, 2014
Distribution
Nationwide, Puerto Rico, and U.S. Virgin Islands.

View recall →

Drug Recall Terminated Historical recordClass II

Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015 by Baxter Healthcare Corporation 250 Road 144 Jayuya, Puerto Rico, 00664, NDC 0338-0431-03

by Baxter Healthcare Corp.

Reason
Subpotent Drug: Heparin raw material was found to have low potency
Recall initiated
October 30, 2014
Reported by FDA
December 3, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-6427-90

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

HCG - 10,000 Unit PF Inject, 1mL Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS NDC 88888-0216-49

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5036-49

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

HCG-20,000 U/2 mL Vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2195-47

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5120-67

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

HCG 200 IU/mL Injection, 30Ml, 10 mL vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7745-68

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

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.