FDA recall D-0804-2026

Product

Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3

Reason for recall

Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2026-08-13

Report date

2026-09-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0804-2026