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.

Blossom Pharmaceuticals

US Class II Ongoing · initiated 2025-10-31

cGMP deviations

Blossom Pharmaceuticals

US Class II Ongoing · initiated 2025-10-31

cGMP deviations

Novocol Pharmaceutical of Canada, Inc.

US Class II Ongoing · initiated 2025-10-31

Defective container: cracked/broken cartridges

Novocol Pharmaceutical of Canada, Inc.

US Class II Ongoing · initiated 2025-10-31

Defective container: cracked/broken cartridges

Novocol Pharmaceutical of Canada, Inc.

US Class II Ongoing · initiated 2025-10-31

Defective container: cracked/broken cartridges

Novocol Pharmaceutical of Canada, Inc.

US Class II Ongoing · initiated 2025-10-31

Defective container: cracked/broken cartridges

Novocol Pharmaceutical of Canada, Inc.

US Class II Ongoing · initiated 2025-10-31

Defective container: cracked/broken cartridges

Novocol Pharmaceutical of Canada, Inc.

US Class II Ongoing · initiated 2025-10-31

Defective container: cracked/broken cartridges

Novocol Pharmaceutical of Canada, Inc.

US Class II Ongoing · initiated 2025-10-31

Defective container: cracked/broken cartridges

Ozempic solution

Canada Type II Ongoing · initiated 2025-10-31

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…

Otsuka ICU Medical LLC

US Class I Ongoing · initiated 2025-10-29

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORI…

Otsuka ICU Medical LLC

US Class I Ongoing · initiated 2025-10-29

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORI…

SUN PHARMACEUTICAL INDUSTRIES INC

US Class II Ongoing · initiated 2025-10-28

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 6…

SUN PHARMACEUTICAL INDUSTRIES INC

US Class II Ongoing · initiated 2025-10-28

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 6…

SUN PHARMACEUTICAL INDUSTRIES INC

US Class II Ongoing · initiated 2025-10-28

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 6…

SUN PHARMACEUTICAL INDUSTRIES INC

US Class II Ongoing · initiated 2025-10-28

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 6…

SUN PHARMACEUTICAL INDUSTRIES INC

US Class II Ongoing · initiated 2025-10-28

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 6…

SUN PHARMACEUTICAL INDUSTRIES INC

US Class II Ongoing · initiated 2025-10-28

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 6…

SUN PHARMACEUTICAL INDUSTRIES INC

US Class II Ongoing · initiated 2025-10-28

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 6…

Agebox

US Class II Ongoing · initiated 2025-10-28

Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren

Agebox

US Class II Ongoing · initiated 2025-10-28

Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren

Otsuka ICU Medical LLC

US Class II Ongoing · initiated 2025-10-27

Lack of Assurance of Sterility: Potential for flexible container leaks.

JAMP SERTRALINE 50mg

Canada Type III Ongoing · initiated 2025-10-27

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…

Cipla USA, Inc.

US Class II Ongoing · initiated 2025-10-24

Failed stability specifications: Out of specification for hardness test

Cipla USA, Inc.

US Class II Ongoing · initiated 2025-10-24

Failed stability specifications: Out of specification for hardness test