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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 1,721–1,740 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00

by B. Braun Medical Inc

Reason
Lack of assurance of sterility: bags have the potential to leak..
Recall initiated
March 22, 2024
Reported by FDA
April 10, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Recall initiated
March 26, 2024
Reported by FDA
April 10, 2024
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass I

Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01

by Par Sterile Products LLC

Reason
Presence of Particulate Matter.
Recall initiated
March 4, 2024
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62

by Teva Pharmaceuticals USA, Inc

Reason
Failed Dissolution Specifications
Recall initiated
March 7, 2024
Reported by FDA
April 3, 2024
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01

by Apothecus Pharmaceutical Corp.

Reason
cGMP Diviations
Recall initiated
March 21, 2024
Reported by FDA
April 3, 2024
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10

by Amneal Pharmaceuticals of New York, LLC

Reason
Failed dissolution specifications
Recall initiated
December 26, 2023
Reported by FDA
April 3, 2024
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 9, 2023
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 9, 2023
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 70004090812

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 9, 2023
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 9, 2023
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID for KitCheck compatibility)

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 9, 2023
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612.

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 9, 2023
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 9, 2023
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112.

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 9, 2023
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 9, 2023
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 9, 2023
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 70004081011

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 9, 2023
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 9, 2023
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 9, 2023
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159

by SCA Pharmaceuticals, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
November 9, 2023
Reported by FDA
April 3, 2024
Distribution
Nationwide in the USA

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.