Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA drug recalls in 2013

Every FDA drug recall initiated in 2013, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

2,085 recalls, newest first.

Class II · Moderate risk

Gentamycin 80mg/1000cc 0.9% NS

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-1115-2014
Class II · Moderate risk

Folic acid

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-1114-2014
Class II · Moderate risk

5-Fluorouracil 1% ophthal

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-1113-2014
Class II · Moderate risk

5-Fluorouracil pf in methocel 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-1112-2014
Class II · Moderate risk

EDTA 3% ophthalmic

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-1111-2014
Class II · Moderate risk

Ethanol 20% ophthal.

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-1110-2014
Class II · Moderate risk

Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg

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-1109-2014
Class II · Moderate risk

Dexamethasone phosphate 24mg/ml inj.

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-1108-2014
Class II · Moderate risk

Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic

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-1107-2014
Class II · Moderate risk

Dexamethasone

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-1106-2014
Class II · Moderate risk

Cyano B-12

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-1105-2014
Class II · Moderate risk

Cyano B-12 p-f 1000mcg/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-1104-2014
Class II · Moderate risk

Cyanocobalamin 100mcg/ml injection

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-1103-2014
Class II · Moderate risk

Bleomycin Sulfate 1unit/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-1102-2014
Class II · Moderate risk

Bladder Instillation

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-1101-2014
Class II · Moderate risk

AMP/M-B12/Pyridox/Methionine Inositol

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-1100-2014
Class II · Moderate risk

Acetylcysteine 10% ophthalmic

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-1099-2014
Class II · Moderate risk

Lidocaine 4% Urethral Gel

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-1098-2014
Class II · Moderate risk

Acetaminophen suspension liquid

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

Terminated Packaging defect L. Perrigo Co. NDC 49035-946-16 D-006-2014
Class II · Moderate risk

Acetaminophen suspension liquid

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

Terminated Packaging defect L. Perrigo Co. NDC 36800-766-16 D-005-2014
Class II · Moderate risk

Acetaminophen suspension liquid

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

Terminated Packaging defect L. Perrigo Co. NDC 37205-577-16 D-004-2014
Class II · Moderate risk

Acetaminophen suspension liquid

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

Terminated Packaging defect L. Perrigo Co. NDC 41163-590-16 D-003-2014
Class III · Low risk

Acyclovir Oral Suspension

Failed Stability Specification; product viscosity and or pH are below specification.

Terminated Stability / shelf life Hi-Tech Pharmacal Co., Inc. NDC 50383-810-16 D-389-2014

Recalls by year