FDA recall D-0528-2025

Product

Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90

Reason for recall

Failed Impurity/Degradation Specifications

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-06-26

Report date

2025-07-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0528-2025