Where's it on?
FDA · Drugs ·

Paxil CR, Paroxetine recall

Apotex Corp. recalled Paxil CR, Paroxetine on September 2, 2026 because of failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria. It was sold nationwide.

Why it was recalled

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

What's recalled

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

Quantity: 6,972 bottles

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Apotex Corp., Weston, FL
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
US Nationwide.
Status
Ongoing
Recall number
D-0804-2026
Source
U.S. Food and Drug Administration

More drugs recalls

TRP The Relief Products* Gentle Eyes Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCAvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCClear Eyes Redness Relief
· Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare companyAvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCLubricant Eye Drops-Cameron Pharmaceuticals
· Sterling Pharmaceutical Services LLCReliable -1 Laboratories
· Sterling Pharmaceutical Services LLC