Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 9,801–9,820 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix Toronto, M2J4W8, UPC 057800062653

by Oxygen Development Llc

Reason
Superpotent drug: failed assay throughout the stick after 6 months stability.
Recall initiated
January 24, 2018
Reported by FDA
March 14, 2018
Distribution
Canada

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1

by Spirit Pharmaceuticals, LLC

Reason
CGMP deviations: Ibuprofen is being recalled in response to previous recall
Recall initiated
January 10, 2018
Reported by FDA
March 14, 2018
Distribution
NY

View recall →

Drug Recall Terminated Historical recordClass II

Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05

by Kalchem International, Inc.

Reason
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Recall initiated
February 19, 2018
Reported by FDA
March 14, 2018
Distribution
TX

View recall →

Drug Recall Terminated Historical recordClass III

Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10

by Osmotica Pharmaceutical Corp

Reason
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Recall initiated
February 28, 2018
Reported by FDA
March 14, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-264-25.

by Apollo Care

Reason
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Recall initiated
February 15, 2018
Reported by FDA
March 14, 2018
Distribution
Medical Facility in MO

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.

by Apollo Care

Reason
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Recall initiated
February 15, 2018
Reported by FDA
March 14, 2018
Distribution
Medical Facility in MO

View recall →

Drug Recall Terminated Historical recordClass III

Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05

by Akorn, Inc.

Reason
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Recall initiated
February 21, 2018
Reported by FDA
March 14, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25.

by Hospira Inc. A Pfizer Company

Reason
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Recall initiated
February 20, 2018
Reported by FDA
March 14, 2018
Distribution
Nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass I

Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46

by AuroMedics Pharma LLC

Reason
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Recall initiated
January 12, 2018
Reported by FDA
March 7, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04

by Kareway Products Inc

Reason
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Recall initiated
November 9, 2017
Reported by FDA
March 7, 2018
Distribution
Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01

by LEADIANT BIOSCIENCES, INC

Reason
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Recall initiated
February 14, 2018
Reported by FDA
March 7, 2018
Distribution
Product was distributed to one specialty pharmacy distributor in the US Walgreens Specialty Pharmacy 16287, 130 Enterprise Drive Pittsburgh, PA 15275 Foreign Account: Italy

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
Recall initiated
February 16, 2018
Reported by FDA
March 7, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120

by Fagron, Inc

Reason
Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
Recall initiated
February 14, 2018
Reported by FDA
March 7, 2018
Distribution
Nationwide, USA

View recall →

Drug Recall Terminated Historical recordClass II

PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 53329-938-04

by Medline Industries Inc

Reason
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Recall initiated
February 15, 2018
Reported by FDA
March 7, 2018
Distribution
Nationwide in the USA and Curacao

View recall →

Drug Recall Terminated Historical recordClass II

INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013.

by ALLERGAN

Reason
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Recall initiated
December 13, 2017
Reported by FDA
March 7, 2018
Distribution
Product was distributed nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478

by Apace KY LLC

Reason
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Recall initiated
February 9, 2018
Reported by FDA
March 7, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

by American Pharmaceutical Ingredients LLC

Reason
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Recall initiated
February 9, 2018
Reported by FDA
February 28, 2018
Distribution
Nationwide within USA.

View recall →

Drug Recall Terminated Historical recordClass II

Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 58597-8044-1), b) 5g (NDC 58597-8044-2), c) 25g (NDC 58597-8044-4), d) 100g (NDC 58597-8044-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

by American Pharmaceutical Ingredients LLC

Reason
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Recall initiated
February 9, 2018
Reported by FDA
February 28, 2018
Distribution
Nationwide within USA.

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8056-2); c) 5g (NDC 58597-8056-3); d) 10g (NDC 58597-8056-4), e) 25 g (NDC 58597-8056-4); f) 100g (NDC 58597-8056-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

by American Pharmaceutical Ingredients LLC

Reason
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Recall initiated
February 9, 2018
Reported by FDA
February 28, 2018
Distribution
Nationwide within USA.

View recall →

Drug Recall Terminated Historical recordClass II

Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2); c) 5g (NDC 58597-8142-3); d ) 25g (NDC 58597-8142-4), Rx only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

by American Pharmaceutical Ingredients LLC

Reason
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Recall initiated
February 9, 2018
Reported by FDA
February 28, 2018
Distribution
Nationwide within 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.