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.

OPTIMAL BALANCE PHARMACY

US Class I Ongoing · initiated 2026-08-05

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Novartis Pharmaceuticals Corporation

US Class II Ongoing · initiated 2026-08-04

Failed Dissolution Specifications

Fresenius Kabi USA, LLC

US Class I Ongoing · initiated 2026-08-04

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Shoolin Pharma Chem LLP

US Class II Ongoing · initiated 2026-08-03

CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP

US Class II Ongoing · initiated 2026-08-03

CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP

US Class II Ongoing · initiated 2026-08-03

CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP

US Class II Ongoing · initiated 2026-08-03

CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP

US Class II Ongoing · initiated 2026-08-03

CGMP Deviations:Noted during FDA inspection

SUN PHARMACEUTICAL INDUSTRIES INC

US Class II Ongoing · initiated 2026-08-03

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Lupin Pharmaceuticals Inc.

US Class II Ongoing · initiated 2026-08-03

Failed content uniformity specifications.

Liebel-Flarsheim Company LLC

US Class I Ongoing · initiated 2026-07-31

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

Femyso Mifepristone 200mg / Misoprostol 200 mcg tablet

Canada Type II Ongoing · initiated 2026-07-30

Packaging. Verify whether your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product, or if you have any healt…

Pharmasave Regular Strength Dairy Digestive Supplement Lactase Enzyme

Canada Unclassified Ongoing · initiated 2026-07-30

Labelling. Verify whether your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concer…

Heritage Pharmaceuticals Inc

US Class II Ongoing · initiated 2026-07-30

Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

Apollo Care, LLC

US Class II Ongoing · initiated 2026-07-29

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC

US Class II Ongoing · initiated 2026-07-29

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC

US Class II Ongoing · initiated 2026-07-29

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC

US Class II Ongoing · initiated 2026-07-29

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC

US Class II Ongoing · initiated 2026-07-29

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC

US Class II Ongoing · initiated 2026-07-29

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Prestige Brands Holdings

US Class II Ongoing · initiated 2026-07-29

Lack of assurance of sterility. The recall is due to potential contamination

Apollo Care, LLC

US Class II Ongoing · initiated 2026-07-29

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC

US Class II Ongoing · initiated 2026-07-29

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC

US Class II Ongoing · initiated 2026-07-29

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC

US Class II Ongoing · initiated 2026-07-29

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material