Reported Dec 6, 2023 · Ongoing

Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex…

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?

    • Paroxetine Hydrochloride Tablets USP
    • RX only
    • 40 mg
    • 1000-count bottle
    • NDC#:60505-0101-4
  • Manufactured byApotex Inc., Toronto, Ontario, Canada M9L 1T9
  • Manufactured forApotex Corp., Weston, Florida 33326
Lot codes and dates
  • Lot numbers
    • RV0131
    • RV2387
    • RV2389
    • RW3296
    • RV2388
    • Exp. 08/2024
Amount recalled
4,074

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

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 (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:02 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.