Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

FDA Drug Recalls

5,405 recalls, newest first

Class II · Moderate risk

ROHTO Redness Relief

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Terminated Sterility / contamination The Mentholatum Co. D-1038-2014
Class II · Moderate risk

ROHTO Redness Relief

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Terminated Sterility / contamination The Mentholatum Co. D-1037-2014
Class II · Moderate risk

Vitamin B-12 injections

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Terminated Sterility / contamination Zions RX Formulations Services LLC dba RX Formuations Serv. D-1219-2014
Class II · Moderate risk

Bupivacaine 3%

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Terminated Sterility / contamination Zions RX Formulations Services LLC dba RX Formuations Serv. D-1218-2014
Class II · Moderate risk

Sodium Bicarbonate 8.4%

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Terminated Sterility / contamination Zions RX Formulations Services LLC dba RX Formuations Serv. D-1217-2014
Class II · Moderate risk

Potassium Phosphates 4.4mEq/3mM/mL Vials

Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Terminated Sterility / contamination Zions RX Formulations Services LLC dba RX Formuations Serv. D-1215-2014
Class I · High risk

Calcium Gluconate 10% for Injection

Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe.

Terminated Sterility / contamination Zions RX Formulations Services LLC dba RX Formuations Serv. D-1213-2014
Class I · High risk

Glycopyrrolate

Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.

Terminated Sterility / contamination Brookfield Prescription Center Inc D-1252-2014
Class II · Moderate risk

10%, Travasol

Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured

Terminated Sterility / contamination Baxter Healthcare Corp. D-368-2014
Class II · Moderate risk

Sumatriptan Succinate Injection

Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.

Terminated Sterility / contamination GlaxoSmithKline, LLC. NDC 0781-3173-07 D-388-2014
Class II · Moderate risk

Imitrex STATdose System

Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.

Terminated Sterility / contamination GlaxoSmithKline, LLC. NDC 0173-0479-00 D-387-2014
Class II · Moderate risk

PEGASPARGASE ONCASPAR Injection

Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of five lots of Oncaspar Injection, because of a crack under the crimp seal which caused a leak.

Terminated Sterility / contamination Sigma-Tau Pharmaceuticals, Inc. NDC 54482-301-01 D-736-2014
Class II · Moderate risk

Voriconazole 0.5mg/ml

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Natures Pharmacy & Compounding Center D-1145-2014
Class II · Moderate risk

Voriconazole 0.5mg/ml

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Natures Pharmacy & Compounding Center D-1144-2014
Class II · Moderate risk

Voriconazole 1% opthal

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Natures Pharmacy & Compounding Center D-1143-2014
Class II · Moderate risk

Vitamin D (Ergocalciferol)

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Natures Pharmacy & Compounding Center D-1142-2014
Class II · Moderate risk

Vit A (olive oil)

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Natures Pharmacy & Compounding Center D-1141-2014
Class II · Moderate risk

Vancomycin

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Natures Pharmacy & Compounding Center D-1140-2014
Class II · Moderate risk

Triamcinolone Acetonide 3mg/ml

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Natures Pharmacy & Compounding Center D-1139-2014

Recalls by year