D-0877-2026 Class II Ongoing
FDA drug recall D-0877-2026 was initiated by Apotex Corp. on Sep 23, 2026 and is designated Class II. Reason for recall: Failed dissolution specifications. The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 7, 2026
- Initiation Date
- Sep 23, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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 60505-1318-3
Reason for Recall
Failed dissolution specifications.
Distribution Pattern
US Nationwide.
Code Information
Lot# TY9495, Exp Date: 05/2027.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0877-2026
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026