Reported Sep 2, 2026 · Ongoing · Updated Sep 16, 2026

Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc.,…

Apotex Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Apotex Corp. · 2400 N Commerce Pkwy Ste 400 · Weston, FL · 33326-3253

Is this the product you have?

  • Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only
  • Manufactured byApotex Inc., Toronto, Ontario, Canada M9L 1T9
  • Manufactured forApotex Corp., Weston, Florida 33326, NDC 60505-4379-3
Lot codes and dates
  • Lot # TY9494
  • Exp Date05/31/2027
Amount recalled
6,972 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 6:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.