Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg
Recalled by Apotex Corp.
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Apotex Corp. has recalled Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on September 2, 2026 and was initiated on August 13, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, with approximately 6,972 bottles affected. The company behind the recall is Apotex Corp., based in Weston, FL. The FDA describes the product as: “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”
Why was Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled?
According to the FDA, the stated reason for the recall is: “Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria.” In plain terms, this recall relates to a potency or effectiveness issue.
This recall means the medicine may be stronger or weaker than its label says, or may not release its ingredient the way it should. That matters because too little medicine may not treat the condition, and too much can cause side effects. Anyone taking an affected product is generally advised to consult their pharmacist or doctor about a replacement.
What should you do?
If you think you may have bought Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, compare it against the product description and identifying codes (Lot # TY9494, Exp Date: 05/31/2027.) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Apotex Corp. or your local health authority.
About this recall
This recall was distributed in FL. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Who this recall affects
This recall matters to anyone who bought Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg. Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.
Distribution listed in the notice: US Nationwide..
What potency or effectiveness issue actually means
This recall means the medicine may be stronger or weaker than its label says, or may not release its ingredient the way it should. That matters because too little medicine may not treat the condition, and too much can cause side effects. Anyone taking an affected product is generally advised to consult their pharmacist or doctor about a replacement.
In this case, the concern applies specifically to Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg from Apotex Corp. — not to the wider category of products. Similar items from other brands aren't part of this recall.
How to check whether you have it
On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.
Compare what you find against the identifying details in this recall: Lot # TY9494, Exp Date: 05/31/2027.
What to do if you already bought it
Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.
Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.
If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.
Full recall details
- Status
- Ongoing
- Date reported
- September 2, 2026
- Recall started
- August 13, 2026
- Distributed in
- FL
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled?+
According to the FDA: Failed Dissolution Specifications;
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0804-2026. Information last synced from the FDA on September 7, 2026.