US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

Amiodarone 900 mg in dextrose 5% 500 mL

Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

SSM Health Care St. Louis DBA SSM St. Clare Health Center D-0137-2018
Class II · Moderate risk Terminated

Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL

Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.

SSM Health Care St. Louis DBA SSM St. Clare Health Center D-0136-2018
Class II · Moderate risk Terminated

Neostigmine Methylsulfate

Reason Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.

Premier Pharmacy Labs Inc NDC 69623-234-15 D-0129-2018
Class II · Moderate risk Terminated

Povidone Iodine

Reason Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.

Degasa Sa De Cv NDC 68345-350-09 D-1129-2017
Class II · Moderate risk Terminated

Procrit Epoetin Alfa 40

Reason Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.

Amgen, Inc. NDC 59676-340-01 D-1086-2017
Class II · Moderate risk Terminated

Vitamin A&D Ointment

Reason Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.

Medline Industries INC D-1138-2017
Class II · Moderate risk Terminated

Rugby Senexon Liquid Natural Vegetable Stimulant

Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

The Harvard Drug Group NDC 0536-1000-59 D-1123-2017
Class II · Moderate risk Terminated

Rugby Aller-chlor

Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

The Harvard Drug Group D-1122-2017
Class II · Moderate risk Terminated

Major Senna Syrup Natural Vegetable Laxative

Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

The Harvard Drug Group D-1121-2017
Class II · Moderate risk Terminated

Rugby Diocto Syrup

Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

The Harvard Drug Group D-1120-2017
Class II · Moderate risk Terminated

Rugby Diocto Liquid

Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

The Harvard Drug Group D-1119-2017
Class II · Moderate risk Terminated

Famotidine USP 20 mg

Reason Failed Tablet/Capsule Specification: out of specification for tablet weight.

PD-Rx Pharmaceuticals, Inc. NDC 55289-765-30 D-1057-2017
Class II · Moderate risk Terminated

0.9% Sodium Chloride Injection

Reason Presence of Particulate Matter; stainless steel

ICU Medical Inc NDC 0409-7983-09 D-1091-2017
Class II · Moderate risk Terminated

Hydromorphone Hydrochloride Injection

Reason Presence of Particulate Matter: Silicone oil

Hospira INC, Lake Forest NDC 0703-0113-01 D-1082-2017
Class II · Moderate risk Terminated

Famotidine Tablets USP

Reason Failed Tablet/Capsule Specification; out of specification for tablet weight

Teva Pharmaceuticals USA NDC 0172-5728-60 D-1056-2017
Class II · Moderate risk Terminated

Entecavir Tablets 0.5 mg

Reason Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.

Hetero USA Inc NDC 31722-833-30 D-1095-2017
Class II · Moderate risk Terminated

Magnesium Citrate Oral Solution

Reason Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.

Vi-Jon, Inc. NDC 50804-686-38 D-1054-2017