Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, C
Summary
The FDA issued a Class II for Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactu by Apotex Corp.. Reason: Failed dissolution specifications..
Details
Source
Drug Recall
External ID
D-0877-2026
Action Date
2026-10-07
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot# TY9495, Exp Date: 05/2027.
Reason for Recall
Failed dissolution specifications.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-23
Company
Weston, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 23 drug recalls issued in the same week, part of 40 drug-related FDA actions this month.
Apotex Corp. has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Apotex Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Apotex Corp. have FDA actions?
Apotex Corp. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0877-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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