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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 1161–1180 of 17,683 recalls

Class IITerminated

Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05

JR Watkins

cGMP Deviations

November 1, 2024 · DrugView details →

Class IIOngoing

Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3

Noven Pharmaceuticals Inc

Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).

October 31, 2024 · DrugView details →

Class IIOngoing

Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01

Baxter Healthcare Corporation

Labeling: Missing Label

October 30, 2024 · DrugView details →

Class IIOngoing

Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.

VIONA PHARMACEUTICALS INC

Crystallization

October 29, 2024 · DrugView details →

Class IIIOngoing

IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05

Dr. Reddy's Laboratories, Inc.

Failed Tablet/Capsule Specifications

October 29, 2024 · DrugView details →

Class IIOngoing

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

FDC Limited

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

October 29, 2024 · DrugView details →

Class IITerminated

Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37

Lannett Company Inc.

Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.

October 25, 2024 · DrugView details →

Class IITerminated