Data Composite

Drug Recalls

Recent drug recall reports from the FDA (US) and Health Canada, newest first. Each entry links to the full record -- product description, reason for recall, and severity classification -- refreshed daily.

Breckenridge Pharmaceutical, Inc.

US Class II Ongoing · initiated 2025-07-25

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Cipla USA, Inc.

US Class III Ongoing · initiated 2025-07-24

Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month t…

Apo-Lisdexamfetamine 30mg

Canada Type II Ongoing · initiated 2025-07-23

Product quality. Verify if your product is affected. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health c…

Hikma Pharmaceuticals USA Inc.

US Class II Ongoing · initiated 2025-07-22

Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds

Taizhou Kangping Medical Science And Technology Co., Ltd.

US Class II Ongoing · initiated 2025-07-22

Lack of Assurance of Sterility.

Ascend Laboratories, LLC

US Class II Ongoing · initiated 2025-07-21

Failed Dissolution Specifications: low dissolution results

Merck & Co. Inc

US Class II Ongoing · initiated 2025-07-21

Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying …

YANGZHOU YULOU PAPER PRODUCTS CO., LTD

US Class II Ongoing · initiated 2025-07-21

cGMP Deviations

AEQUITA PHARMACY

US Class II Ongoing · initiated 2025-07-18

Lack of Processing Controls.

AEQUITA PHARMACY

US Class II Ongoing · initiated 2025-07-18

Lack of Processing Controls.

AEQUITA PHARMACY

US Class II Ongoing · initiated 2025-07-18

Lack of Processing Controls.

AEQUITA PHARMACY

US Class II Ongoing · initiated 2025-07-18

Lack of Processing Controls.

AEQUITA PHARMACY

US Class II Ongoing · initiated 2025-07-18

Lack of Processing Controls.

AEQUITA PHARMACY

US Class II Ongoing · initiated 2025-07-18

Lack of Processing Controls.

AEQUITA PHARMACY

US Class II Ongoing · initiated 2025-07-18

Lack of Processing Controls.

AEQUITA PHARMACY

US Class II Ongoing · initiated 2025-07-18

Lack of Processing Controls.

AEQUITA PHARMACY

US Class II Ongoing · initiated 2025-07-18

Lack of Processing Controls.

AEQUITA PHARMACY

US Class II Ongoing · initiated 2025-07-18

Lack of Processing Controls.

AEQUITA PHARMACY

US Class II Ongoing · initiated 2025-07-18

Lack of Processing Controls.

AEQUITA PHARMACY

US Class II Ongoing · initiated 2025-07-18

Lack of Processing Controls.

AEQUITA PHARMACY

US Class II Ongoing · initiated 2025-07-18

Lack of Processing Controls.

DermaRite Industries, LLC

US Class I Ongoing · initiated 2025-07-17

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

DermaRite Industries, LLC

US Class I Ongoing · initiated 2025-07-17

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

DermaRite Industries, LLC

US Class I Ongoing · initiated 2025-07-17

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

DermaRite Industries, LLC

US Class I Ongoing · initiated 2025-07-17

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.