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.

Boulla LLC

US Class I Ongoing · initiated 2024-11-04

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Boulla LLC

US Class I Ongoing · initiated 2024-11-04

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Boulla LLC

US Class I Ongoing · initiated 2024-11-04

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Florabile

Canada Type II Ongoing · initiated 2024-11-04

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…

Dead Down Wind Broad Spectrum SPF 30 Odourless Lip Balm

Canada Type III Ongoing · initiated 2024-11-04

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…

JR Watkins

US Class II Terminated · initiated 2024-11-01

cGMP Deviations

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2024-11-01

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2024-11-01

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2024-11-01

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2024-11-01

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2024-11-01

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2024-11-01

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Noven Pharmaceuticals Inc

US Class II Ongoing · initiated 2024-10-31

Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).

Baxter Healthcare Corporation

US Class II Ongoing · initiated 2024-10-30

Labeling: Missing Label

VIONA PHARMACEUTICALS INC

US Class II Ongoing · initiated 2024-10-29

Crystallization

FDC Limited

US Class II Ongoing · initiated 2024-10-29

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Dr. Reddy's Laboratories, Inc.

US Class III Ongoing · initiated 2024-10-29

Failed Tablet/Capsule Specifications

Lannett Company Inc.

US Class II Terminated · initiated 2024-10-25

Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.

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

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