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

18,003 recalls, newest first

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
Class II · Moderate risk

Tacrolimus Capsules

Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin

Terminated Cross-contamination Sandoz Incorporated NDC 0781-2102-01 D-383-2014
Class I · High risk

Human Chorionic Gonadotropin

Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.

Terminated Labeling / mix-up Medisca Inc. NDC 38779-2673-1 D-1263-2014
Class II · Moderate risk

Sodium Hydroxide

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-460-2014
Class II · Moderate risk

DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 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-459-2014
Class II · Moderate risk

Calcium Chloride* PF 500 mg/mL pref syringe

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-457-2014
Class II · Moderate risk

WB-Tranexamic acid

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-456-2014

Recalls by year