FDA recall, , Moderate risk
Apotex Paxil CR, Paroxetine, Extended-Release Tablets
Paxil CR tablets failed dissolution specifications and stability testing acceptance criteria.
Summary by Recall Canary from the FDA notice
What happened
Apotex Corp. of Weston, Florida, is recalling Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, in 30 count bottles, because the product failed dissolution specifications and did not meet 24-month stability testing acceptance criteria. The recall began on August 13, 2026, and was added to the FDA's Enforcement Report on August 27, 2026.
The tablets were manufactured by Apotex Inc. in Toronto, Ontario, Canada, and distributed nationwide in the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Paxil CR, Paroxetine, Extended-Release Tablets
- NDC
- 60505-4379-3
- Lot code
- TY9494
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Apotex Corp.Weston, Florida
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99673
- Recall number
- D-0804-2026
- Quantity recalled
- 6,972 bottles
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
