Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

657 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2013 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-447-2014
Class II · Moderate risk

Sodium Thiosulfate PF

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-446-2014
Class II · Moderate risk

Sodium tetradecyl SO4

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-445-2014
Class II · Moderate risk

SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-444-2014
Class II · Moderate risk

QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-443-2014
Class II · Moderate risk

Proparacaine HCl PF

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-442-2014
Class II · Moderate risk

Potassium Phosphate* Pf 4.4 Meq

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-441-2014
Class II · Moderate risk

Polidocanol

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-440-2014
Class II · Moderate risk

Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-439-2014
Class II · Moderate risk

Phenol

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-438-2014
Class II · Moderate risk

Papaverine HCL

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-437-2014
Class II · Moderate risk

Papav/Phentol/PG E1

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-436-2014
Class II · Moderate risk

Neomycin Sulfate* ophthalmic solution

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-435-2014
Class II · Moderate risk

Naltrexone* Mdv 1mg/Ml Injectable

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-434-2014
Class II · Moderate risk

Naloxone HCL* 0.4mg/Ml Injectable

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-433-2014
Class II · Moderate risk

Multitrace-4 pediatric injection

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-432-2014
Class II · Moderate risk

METHYLCOBALAMIN * 10 mg/mL INJECTABLE

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-431-2014
Class II · Moderate risk

Methocarbamol

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-430-2014
Class II · Moderate risk

Magnesium Sulfate

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-429-2014
Class II · Moderate risk

Lidocaine/Sodium Chl* 0.4 %/18 % Injectable

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-428-2014
Class II · Moderate risk

HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-427-2014
Class II · Moderate risk

Hydroxocobalamin* 10

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-426-2014
Class II · Moderate risk

Hyaluronidase

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-425-2014
Class II · Moderate risk

Glycerin-Chromated

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-424-2014
Class II · Moderate risk

Glutathione PF

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-423-2014

Recalls by year