FDA Drug Recalls

11,818 recalls · Class II, newest first

Sep 24, 2013 Class II · Moderate risk

Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula

Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.

Terminated Microbial contamination W.S. Badger Company Inc. D-324-2014

Sep 24, 2013 Class II · Moderate risk

Ondansetron Injection

Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-4755-03 D-013-2014

Sep 24, 2013 Class II · Moderate risk

Metoclopramide Injection

Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-3414-01 D-012-2014

Sep 23, 2013 Class II · Moderate risk

Irinotecan Hydrochloride Injection

Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.

Terminated Wrong potency / content West-Ward Pharmaceutical Corp. NDC 0143-9701-01 D-66447-002

Sep 23, 2013 Class II · Moderate risk

Irinotecan Hydrochloride Injection

Terminated Wrong potency / content West-Ward Pharmaceutical Corp. NDC 0143-9702-01 D-66447-001

Sep 23, 2013 Class II · Moderate risk

Next Choice" One Dose Emergency Contraceptive

Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.

Terminated Failed specification Watson Laboratories Inc NDC 52544-287-54 D-66360-001

Sep 17, 2013 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

Sep 17, 2013 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

Sep 17, 2013 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

Sep 17, 2013 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

Sep 17, 2013 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

Sep 17, 2013 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

Sep 16, 2013 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

Sep 16, 2013 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

Sep 13, 2013 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

Sep 13, 2013 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

Sep 13, 2013 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

Sep 13, 2013 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

Sep 13, 2013 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

Sep 13, 2013 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

Sep 13, 2013 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

Sep 13, 2013 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

Sep 13, 2013 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

Sep 13, 2013 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

Sep 13, 2013 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

Recalls by year

2026563
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061