US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Class III · Low risk Terminated

Esterified Estrogens & Methyltestosterone Tablets

Reason Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.

Amneal Pharmaceuticals, Inc. NDC 13925-172-01 D-1439-2019
Class III · Low risk Terminated

Esterified Estrogens & Methyltestosterone Tablets

Reason Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.

Amneal Pharmaceuticals, Inc. NDC 13925-171-01 D-1438-2019
Class III · Low risk Terminated

Ampicillin for Injection

Reason Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.

Sandoz Inc NDC 0781-3407-78 D-1179-2017
Class III · Low risk Terminated

Carbamazepine Oral Suspension USP

Reason Subpotent Drug: low out of specification results.

Precision Dose Inc. NDC 68094-301-59 D-0057-2018
Class II · Moderate risk Terminated

methylPREDNIsolone ACETATE

Reason Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.

RXQ Compounding LLC D-0012-2018
Class III · Low risk Terminated

Mobic

Reason Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.

Boehringer Ingelheim Pharmaceuticals, Inc. NDC 0597-0030-01 D-0007-2018
Class II · Moderate risk Terminated

Medline Incision & Drainage Tray

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0319-2018
Class II · Moderate risk Terminated

Medline Suture Removal Tray

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0318-2018
Class II · Moderate risk Terminated

Medline Suture Removal Tray

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0317-2018
Class II · Moderate risk Terminated

Medline Abdominal Surgery II Pack-LF

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0316-2018
Class II · Moderate risk Terminated

Medline Incision Drainage Tray

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0315-2018
Class II · Moderate risk Terminated

Medline Skin Stapler RMVR

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0314-2018
Class II · Moderate risk Terminated

Professional Hospital Supply Suture Removal Kit

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0313-2018
Class II · Moderate risk Terminated

Medline Suture Removal Pack Latex Safe

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0312-2018
Class II · Moderate risk Terminated

Professional Hospital Supply Suture Removal Kit

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0311-2018
Class II · Moderate risk Terminated

Medline Suture Removal Tray

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0310-2018
Class II · Moderate risk Terminated

Medline Suture Removal Tray

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0309-2018
Class II · Moderate risk Terminated

Medline Incision and Drainage Tray

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0308-2018
Class II · Moderate risk Terminated

Medline Suture Removal Tray

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0307-2018
Class II · Moderate risk Terminated

Medline Anesthesia Kit

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0306-2018
Class II · Moderate risk Terminated

Medline Incision Drainage Kit

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0305-2018
Class II · Moderate risk Terminated

Medline Hip Replacement

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0304-2018
Class II · Moderate risk Terminated

Medline Pacemaker Implant Pack

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0303-2018
Class II · Moderate risk Terminated

Medline Incision and Drainage Tray

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0302-2018
Class II · Moderate risk Terminated

Medline Skin Biopsy Pack-LF

Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Medline Industries Inc D-0301-2018