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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 141–156 of 156 recalls

Class IIIOngoing

Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27

Padagis US LLC

Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.

February 21, 2023 · DrugView details →

Class IIIOngoing

Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02

Akorn, Inc.

Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.

January 30, 2023 · Drug

View details →

Class IIIOngoing

Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10

AuroMedics Pharma LLC

Presence of Particulate Matter: Piece of metal found in a vial

September 26, 2022 · DrugView details →

Class IIIOngoing

Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24

Akorn, Inc

Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.

August 8, 2022 · DrugView details →

Class IIIOngoing

Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.

Glenmark Pharmaceuticals Inc., USA

Defective Container: Tube split from side seam

July 11, 2022 · DrugView details →

Class IIIOngoing

Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-405-60.

Glenmark Pharmaceuticals Inc., USA

Failed Tablet/Capsule Specification : Capsule breakage

June 29, 2022 · DrugView details →

Class IIIOngoing

Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bottles, NDC: 71335-1767-03, barcode 083923153776, e) 90-count bottles, NDC: 71335-1767-04, barcode 083924152889, f) 120-count bottles, NDC: 71335-1767-07, barcode 083927153735. Westminster Pharmaceuticals LLC, Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504 USA

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

September 28, 2021 · DrugView details →

Class IIIOngoing

Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504.

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

September 28, 2021 · DrugView details →

Class IIIOngoing

Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03, DocRx, Mobile, AL 36608

Asclemed USA Inc. dba Enovachem Pharmaceuticals

Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.

March 19, 2021 · DrugView details →

Class IIIOngoing

Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79

AuroMedics Pharma LLC

CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

September 23, 2019 · DrugView details →

Class IIIOngoing

INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01

Cipher Pharmaceuticals US LLC

Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.

December 6, 2016 · DrugView details →

Class IIIOngoing

Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.

Actavis Laboratories, FL, Inc.

Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.

August 30, 2016 · DrugView details →

Class IIIOngoing

Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.

Hospira Inc.

Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.

March 23, 2016 · DrugView details →

Class IIIOngoing

Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02

Hospira Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.

March 15, 2016 · DrugView details →

Class IIIOngoing

Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.

Hospira Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".

February 2, 2016 · DrugView details →

Class IIIOngoing

Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29

Hospira Inc.

Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.

September 29, 2015 · DrugView details →

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