Independent register of U.S. FDA drug recalls · updated Oct 13, 2026
RxRecalls Get alerts

FDA Drug Recalls

11,818 recalls · Class II, newest first

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

Bi-Est (Estriol/Estradiol)

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Terminated Labeling / mix-up KRS Global Biotechnology, Inc D-0168-2018
Class II · Moderate risk

Benzocaine 20%

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Terminated Labeling / mix-up KRS Global Biotechnology, Inc D-0166-2018
Class II · Moderate risk

Benzocaine 20%

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Terminated Labeling / mix-up KRS Global Biotechnology, Inc D-0165-2018
Class II · Moderate risk

Anastrozole SR 1 mg Capsules

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Terminated Labeling / mix-up KRS Global Biotechnology, Inc D-0163-2018
Class II · Moderate risk

Anastrozole 0.5 mg Capsules

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Terminated Labeling / mix-up KRS Global Biotechnology, Inc D-0161-2018
Class II · Moderate risk

Clozapine Tablets USP

Failed Tablet/Capsule Specifications; potential presence of broken tablets.

Terminated Failed specification Teva Pharmaceuticals USA NDC 00093-7772-05 D-0096-2018
Class II · Moderate risk

Estriol

cGMP Deviations: lack of quality assurance at the API manufacturer.

Terminated cGMP deviation Fagron, Inc NDC 51552-1392-5 D-0079-2018
Class II · Moderate risk

Dutasteride and Tamsulosin HCl Capsules

Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.

Terminated Dissolution failure Teva Pharmaceuticals USA NDC 0591-3771-30 D-0069-2018
Class II · Moderate risk

Succinylcholine 20 MG/ML INJ

Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag

Terminated Labeling / mix-up Ace Surgical Supply Co., Inc. D-0071-2018

Recalls by year