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.

MEDLINE INDUSTRIES, LP - Northfield

US Class II Ongoing · initiated 2025-02-17

Subpotent Drug

MEDLINE INDUSTRIES, LP - Northfield

US Class II Ongoing · initiated 2025-02-17

Subpotent Drug

CareFusion 213, LLC

US Class I Ongoing · initiated 2025-02-14

Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.

Zydus Pharmaceuticals (USA) Inc

US Class II Ongoing · initiated 2025-02-13

Failed Impurities/Degradation Specifications

Zydus Pharmaceuticals (USA) Inc

US Class II Ongoing · initiated 2025-02-13

Failed Impurities/Degradation Specifications

Johnson, S C and Son, Inc

US Class II Ongoing · initiated 2025-02-13

Chemical Contamination

ICU Medical, Inc.

US Class I Ongoing · initiated 2025-02-13

Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq

ICU Medical, Inc.

US Class I Ongoing · initiated 2025-02-13

Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The cor…

Johnson, S C and Son, Inc

US Class II Ongoing · initiated 2025-02-13

Chemical Contamination

World Perfumes Inc.

US Class II Ongoing · initiated 2025-02-13

Defective Container: broken or leaking bottles.

Wuxi Medical lnstrument Factory Co., Ltd.

US Class II Ongoing · initiated 2025-02-12

Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.

Nephron Sterile Compounding Center LLC

US Class II Terminated · initiated 2025-02-10

Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.

Aspen Biopharma Labs Pvt., Ltd.

US Class II Ongoing · initiated 2025-02-07

CGMP Deviations

Aspen Biopharma Labs Pvt., Ltd.

US Class II Ongoing · initiated 2025-02-07

CGMP Deviations

Aspen Biopharma Labs Pvt., Ltd.

US Class II Ongoing · initiated 2025-02-07

CGMP Deviations

Aspen Biopharma Labs Pvt., Ltd.

US Class II Ongoing · initiated 2025-02-07

CGMP Deviations

Aspen Biopharma Labs Pvt., Ltd.

US Class II Ongoing · initiated 2025-02-07

CGMP Deviations

Aspen Biopharma Labs Pvt., Ltd.

US Class II Ongoing · initiated 2025-02-07

CGMP Deviations

Padagis US LLC

US Class II Completed · initiated 2025-02-06

Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.

SUN PHARMACEUTICAL INDUSTRIES INC

US Class II Ongoing · initiated 2025-02-06

Failed Dissolution Specifications

BIOV Health Calcium (Carbonate) 300 mg Chewable Tablets

Canada Type II Ongoing · initiated 2025-02-06

Product quality. Verify if your product is affected.Stop taking the affected product and consult your healthcare provider for any health concerns.If you have an…

SENNA Tablet USP ; JAMP Senna ; Jamp - SENNA

Canada Type II Ongoing · initiated 2025-02-05

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…

AvKARE

US Class II Ongoing · initiated 2025-02-04

Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 1…

Ferinject

Canada Type III Ongoing · initiated 2025-02-04

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

Lacosamide Injection 10mg/ml

Canada Type I Ongoing · initiated 2025-02-03

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…