Notice names this product. Apotex’s Paxil CR is named in FDA Class II recall D-0804-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria Identifying details: Lot # TY9494, Exp Date: 05/31/2027.. Units affected: 6,972 bottles. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Company / brand: Apotex recalls
Affected product: Paxil CR recall status
Official ID D-0804-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 12:00 PM UTC.