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

1,803 recalls · Class II, 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

Prolia (denosumab)

Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.

Terminated Particulate / foreign matter Amgen, Inc. NDC 55513-710-01 D-66318-001
Class II · Moderate risk

Quinapril Tablets USP

Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval

Terminated Impurity / degradation Lupin Pharmaceuticals Inc. NDC 68180-557-09 D-409-2014
Class II · Moderate risk

Quinapril Tablets USP

Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval

Terminated Impurity / degradation Lupin Pharmaceuticals Inc. NDC 68180-556-09 D-408-2014
Class II · Moderate risk

Amlodipine Besylate Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-452-20 D-1468-2016
Class II · Moderate risk

Amlodipine Besylate Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-451-20 D-1467-2016
Class II · Moderate risk

Amlodipine Besylate Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-450-20 D-1466-2016
Class II · Moderate risk

Morphine Sulfate Injection

Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the breaking of the vial neck.

Terminated Sterility / contamination Hospira, Inc. NDC 0409-1135-02 D-023-2014
Class II · Moderate risk

Omeprazole Delayed-Release Capsules

Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.

Terminated Failed specification Kremers Urban Pharmaceuticals, Inc. D-009-2014
Class II · Moderate risk

Amlodipine Besylate Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-5210-77 D-66403-012
Class II · Moderate risk

Ciprofloxacin Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-7098-01 D-66403-011
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6900-01 D-66403-010
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6898-01 D-66403-009
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6899-01 D-66403-008
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6897-01 D-66403-007
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6896-01 D-66403-006
Class II · Moderate risk

Amlodipine Besylate Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-5209-77 D-66403-005
Class II · Moderate risk

Ciprofloxacin Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-7097-01 D-66403-004
Class II · Moderate risk

Lamotrigine Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-4254-91 D-66403-003
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6895-01 D-66403-002
Class II · Moderate risk

Amlodipine Besylate Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-5208-77 D-66403-001
Class II · Moderate risk

Oxycodone and Acetaminophen Tablets

Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.

Terminated Particulate / foreign matter Watson Laboratories Inc NDC 0591-0825-01 D-66251-001
Class II · Moderate risk

Ifosfamide Injection 3g/60 mL

Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.

Terminated Temperature excursion AmeriSource Bergen NDC 0069-4496-22 D-1066-2013
Class II · Moderate risk

Ifosfamide Injection 1g/20mL

Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.

Terminated Temperature excursion AmeriSource Bergen NDC 0069-4495-22 D-1065-2013
Class II · Moderate risk

Risperdal CONSTA

Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample

Terminated Sterility / contamination Janssen Pharmaceuticals, Inc. NDC 50458-306-11 D-1514-2014

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