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.

PMS-CINACALCET Tablets (30MG, 60 MG, 90 MG)

Canada Type I Ongoing · initiated 2024-12-30

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…

Eugia US LLC

US Class II Ongoing · initiated 2024-12-27

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

Viatris Inc

US Class II Terminated · initiated 2024-12-23

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

Viatris Inc

US Class II Terminated · initiated 2024-12-23

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

First Aid Beauty Ltd

US Class II Ongoing · initiated 2024-12-23

CGMP Deviations; product intended for quarantine was inadvertently distributed

Astellas Pharma US Inc.

US Class I Ongoing · initiated 2024-12-23

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Astellas Pharma US Inc.

US Class I Ongoing · initiated 2024-12-23

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Jamp Amoxi Clav Suspension

Canada Type II Ongoing · initiated 2024-12-23

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 co…

Lupin Pharmaceuticals Inc.

US Class II Terminated · initiated 2024-12-20

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability s…

ENDO USA, Inc.

US Class I Ongoing · initiated 2024-12-20

Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)

TEVA-Codeine Tablets

Canada Type II Ongoing · initiated 2024-12-20

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…

Hikma Injectables USA Inc

US Class II Terminated · initiated 2024-12-19

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Hikma Injectables USA Inc

US Class II Terminated · initiated 2024-12-19

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

West-Ward Columbus Inc

US Class III Ongoing · initiated 2024-12-19

Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.

AvKARE

US Class III Ongoing · initiated 2024-12-18

LABELING: LABEL MIX-UP

AvKARE

US Class III Ongoing · initiated 2024-12-18

LABELING: LABEL MIX-UP

Granules Pharmaceuticals Inc.

US Class II Terminated · initiated 2024-12-18

Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.

Eugia US LLC

US Class II Ongoing · initiated 2024-12-18

CGMP Deviations

Alcon Research LLC

US Class I Ongoing · initiated 2024-12-18

Non-Sterility

Amerisource Health Services LLC

US Class II Terminated · initiated 2024-12-17

Failed Dissolution Specifications:

SOMERSET THERAPEUTICS LLC

US Class III Terminated · initiated 2024-12-16

Failed Impurities/Degradation Specifications

FDC Limited

US Class II Ongoing · initiated 2024-12-16

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

SHOPPERS- PLAZA

US Class I Ongoing · initiated 2024-12-16

Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide

ANTIHISTAMINE ORAL

Canada Type III Ongoing · initiated 2024-12-16

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…

Amerisource Health Services LLC

US Class II Ongoing · initiated 2024-12-13

Presence of Foreign Tablets/Capsules