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.

Unexo Life Sciences Private Limited

US Class II Terminated · initiated 2024-10-24

cGMP Deviations

Unexo Life Sciences Private Limited

US Class II Terminated · initiated 2024-10-24

cGMP Deviations

Unexo Life Sciences Private Limited

US Class II Terminated · initiated 2024-10-24

cGMP Deviations

Unexo Life Sciences Private Limited

US Class II Terminated · initiated 2024-10-24

cGMP Deviations

Cipla USA, Inc.

US Class II Ongoing · initiated 2024-10-23

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

Cipla USA, Inc.

US Class II Ongoing · initiated 2024-10-23

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

Lupin Pharmaceuticals Inc.

US Class II Terminated · initiated 2024-10-23

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Lupin Pharmaceuticals Inc.

US Class II Terminated · initiated 2024-10-23

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Lupin Pharmaceuticals Inc.

US Class II Terminated · initiated 2024-10-23

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Dr. Reddy's Laboratories, Inc.

US Class II Ongoing · initiated 2024-10-22

Failed Impurities/Degradation Specification

Dr. Reddy's Laboratories, Inc.

US Class II Ongoing · initiated 2024-10-22

Failed Impurities/Degradation Specification

BLI International, Inc.

US Class II Terminated · initiated 2024-10-21

Superpotent Drug: Stability failure for assay at 6 months test time-point.

AvKARE

US Class II Ongoing · initiated 2024-10-18

Labeling: Label Mix-Up

AvKARE

US Class II Ongoing · initiated 2024-10-18

Labeling: Label Mix-Up

Elavil

Canada Type I Ongoing · initiated 2024-10-18

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

Keystone Industries

US Class II Ongoing · initiated 2024-10-17

Subpotent Drug

Apo-Amitriptyline

Canada Type I Ongoing · initiated 2024-10-17

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

Akron Pharma, Inc.

US Class II Ongoing · initiated 2024-10-15

CGMP Deviations

Jamp-Finasteride 5 mg tablet

Canada Type II Ongoing · initiated 2024-10-15

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 co…

Padagis US LLC

US Class III Terminated · initiated 2024-10-11

Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

Stress-B-Plus Tablet

Canada Type II Ongoing · initiated 2024-10-11

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 co…

Breckenridge Pharmaceutical, Inc

US Class II Completed · initiated 2024-10-10

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

ACCORD HEALTHCARE, INC.

US Class II Ongoing · initiated 2024-10-10

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

ACCORD HEALTHCARE, INC.

US Class II Ongoing · initiated 2024-10-10

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

ACCORD HEALTHCARE, INC.

US Class II Ongoing · initiated 2024-10-10

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.