OVERLOOKED

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Class IIOngoing

Apotex Corp. recalls Paroxetine Extended-Release Tablets

Recall date · record updated Oct 7, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Apotex Corp.
Reason
Failed dissolution specifications.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99978…

Products

  1. 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 60505-1318-3

    Codes/lots: Lot# TY9495, Exp Date: 05/2027.Recall no. D-0877-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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