Class IIOngoing
Apotex Corp. recalls Paxil CR
Recall date · record updated Sep 2, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)
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; product failed to meet 24-month stability testing acceptance criteria
- 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=99673…
Products
Paxil CR, 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 60505-4379-3
Codes/lots: Lot # TY9494, Exp Date: 05/31/2027.Quantity: 6,972 bottlesRecall no. D-0804-2026Class II
Update history
- 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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