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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 6,281–6,300 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05

by PharMEDium Services, LLC

Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recall initiated
March 16, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04

by PharMEDium Services, LLC

Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recall initiated
March 16, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50

by PharMEDium Services, LLC

Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recall initiated
March 16, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44

by PharMEDium Services, LLC

Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recall initiated
March 16, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10

by PharMEDium Services, LLC

Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recall initiated
March 16, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01

by PharMEDium Services, LLC

Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recall initiated
March 16, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12

by PharMEDium Services, LLC

Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Recall initiated
March 16, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass III

Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02

by Akorn Inc

Reason
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Recall initiated
March 25, 2020
Reported by FDA
April 8, 2020
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.

by Dr. Reddy's Laboratories, Inc.

Reason
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Recall initiated
March 16, 2020
Reported by FDA
April 8, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass I

Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501

by Y-O Management LLC, dba Natural Remedy Store

Reason
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction
Recall initiated
March 16, 2020
Reported by FDA
April 8, 2020
Distribution
Distributed in GA and TX

View recall →

Drug Recall Terminated Historical recordClass II

Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01

by Lupin Pharmaceuticals Inc.

Reason
Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
Recall initiated
April 1, 2020
Reported by FDA
April 8, 2020
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.

by Medical Center Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated
March 13, 2020
Reported by FDA
April 8, 2020
Distribution
Specific prescriptions to patients in TN

View recall →

Drug Recall Terminated Historical recordClass II

C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02.

by Medical Center Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated
March 13, 2020
Reported by FDA
April 8, 2020
Distribution
Specific prescriptions to patients in TN

View recall →

Drug Recall Terminated Historical recordClass II

*Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 00409-1134-03.

by Medical Center Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated
March 13, 2020
Reported by FDA
April 8, 2020
Distribution
Specific prescriptions to patients in TN

View recall →

Drug Recall Terminated Historical recordClass II

C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.

by Medical Center Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated
March 13, 2020
Reported by FDA
April 8, 2020
Distribution
Specific prescriptions to patients in TN

View recall →

Drug Recall Terminated Historical recordClass II

C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206-0251-05.

by Medical Center Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated
March 13, 2020
Reported by FDA
April 8, 2020
Distribution
Specific prescriptions to patients in TN

View recall →

Drug Recall Terminated Historical recordClass II

Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952

by The Medicine Shoppe Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
March 16, 2020
Reported by FDA
April 8, 2020
Distribution
Florida

View recall →

Drug Recall Terminated Historical recordClass II

Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01

by Par Pharmaceutical Inc.

Reason
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Recall initiated
March 30, 2020
Reported by FDA
April 8, 2020
Distribution
Product was distributed within the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB

by Glaxosmithkline Consumer Healthcare Holdings

Reason
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Recall initiated
March 16, 2020
Reported by FDA
April 1, 2020
Distribution
Product was distributed throughout the United States, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA

by Glaxosmithkline Consumer Healthcare Holdings

Reason
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Recall initiated
March 16, 2020
Reported by FDA
April 1, 2020
Distribution
Product was distributed throughout the United States, including Puerto Rico.

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.