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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 3,221–3,240 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05

by Direct Rx

Reason
cGMP deviation: discontinue of stability support for product.
Recall initiated
November 2, 2022
Reported by FDA
January 18, 2023
Distribution
FL

View recall →

Drug Recall Terminated Historical recordClass II

Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Recall initiated
December 12, 2022
Reported by FDA
January 18, 2023
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
January 6, 2023
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.

by RemedyRePack Inc.

Reason
Failed Impurities/Degradation specifications
Recall initiated
December 20, 2022
Reported by FDA
January 18, 2023
Distribution
Product was distributed to one account in PA.

View recall →

Drug Recall Terminated Historical recordClass II

Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1

by Pine Pharmaceuticals, LLC

Reason
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Recall initiated
December 22, 2022
Reported by FDA
January 11, 2023
Distribution
Nationwide to medical facilities.

View recall →

Drug Recall Completed Historical recordClass II

Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,

by Pfizer Inc.

Reason
Lack of assurance of sterility: Bags have the potential to leak.
Recall initiated
December 29, 2022
Reported by FDA
January 11, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass III

Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Recall initiated
December 27, 2022
Reported by FDA
January 11, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20

by Eugia US LLC

Reason
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Recall initiated
December 28, 2022
Reported by FDA
January 11, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4

by Apotex Corp.

Reason
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
Recall initiated
December 21, 2022
Reported by FDA
January 4, 2023
Distribution
USA Nationwide

View recall →

Drug Recall Completed Historical recordClass II

Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062

by NCH Life Sciences LLC

Reason
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Recall initiated
December 9, 2022
Reported by FDA
January 4, 2023
Distribution
Nationwide in United States and Canada.

View recall →

Drug Recall Completed Historical recordClass II

Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15

by AVKARE LLC

Reason
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Recall initiated
December 22, 2022
Reported by FDA
January 4, 2023
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01

by Hikma Pharmaceuticals USA Inc.

Reason
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Recall initiated
December 16, 2022
Reported by FDA
January 4, 2023
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Recall initiated
December 7, 2022
Reported by FDA
December 28, 2022
Distribution
Product was distributed by major distribution chains nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Recall initiated
December 7, 2022
Reported by FDA
December 28, 2022
Distribution
Product was distributed by major distribution chains 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.