Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto,
Summary
The FDA issued a Class II for Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only by Apotex Corp.. Reason: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria.
Details
Source
Drug Recall
External ID
D-0804-2026
Action Date
2026-09-02
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot # TY9494, Exp Date: 05/31/2027.
Quantity Affected: 6,972 bottles
Reason for Recall
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-13
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 38 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Apotex Corp. has 19 FDA actions in our database, including 19 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 19 FDA actions in our database, including 19 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0804-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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