Class II · Moderate risk Ongoing
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort…
Reason Failed Dissolution Specifications
FDA Drug Recalls
557 recalls, newest first
Class II · Moderate risk Terminated
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
Reason Subpotent Drug and Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
Reason Subpotent Drug and Failed Impurities/Degradation Specifications
Class I · High risk Terminated
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC…
Reason Labeling: Label Mix-up
Class II · Moderate risk Terminated
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark…
Reason Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Class II · Moderate risk Terminated
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Completed
Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA…
Reason Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.