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.

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.

Dr. Reddy's Laboratories, Inc.

US Class II Ongoing · initiated 2024-10-09

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

Dr. Reddy's Laboratories, Inc.

US Class II Ongoing · initiated 2024-10-09

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

Dr. Reddy's Laboratories, Inc.

US Class II Ongoing · initiated 2024-10-09

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

C & A Naturistics

US Class II Ongoing · initiated 2024-10-08

Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.

Neogen Corporation

US Class II Ongoing · initiated 2024-10-08

CGMP violations.

Neogen Corporation

US Class II Ongoing · initiated 2024-10-08

CGMP violations.

Love Bites & Spanish Fly male / female sensual gummies

Canada Type II Ongoing · initiated 2024-10-07

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