Apotex Paroxetine Extended-Release Tablets
Paroxetine Extended-Release Tablets failed dissolution specifications.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Apotex Corp. recalled Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, manufactured by Apotex Inc., because the product failed dissolution specifications. The recall began September 23, 2026, and was added to the FDA's Enforcement Report on September 29, 2026.
Summary by Recall Canary from the FDA notice.
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.
Paroxetine Extended-Release Tablets
- NDC
- 60505-1318-3
- Lot
- TY9495
Details
- Company began the recall
- Sold in
US Nationwide.
- Event ID
- 99978
- Recall No.
- D-0877-2026
- Company
- Apotex Corp.Weston, Florida
- Hazard
- Dissolution failure
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
