FDA-Drug2026-09-02Class IIPROCESSING DEFECT
Apotex Paxil CR paroxetine 37.5mg recalled for failed dissolution specifications
What this means
Apotex Corp. is recalling one lot of Paxil CR (paroxetine) 37.5mg extended-release tablets because the medication failed to meet dissolution specifications during 24-month stability testing. This means the tablets may not release the drug into the body as intended. The affected lot (TY9494, expiration 05/31/2027) was distributed nationwide.
- Check your Paxil CR bottle for lot number TY9494 with expiration date 05/31/2027.
- If you have this lot, contact your pharmacy or prescriber before stopping the medication.
- Do not stop taking paroxetine abruptly without medical guidance.
The agency's original wording
Hazard
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
6,972 bottles
Manufactured in
2400 N Commerce Pkwy Ste 400, N/A, Weston, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0804-2026Want us to check the next one for you?
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