CLASS II ONGOING Drug recall · Reported 2 Sep 2026 · FDA Enforcement Report
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled
Apotex is recalling Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, distributed nationwide in the US. The recall was initiated on 13 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0804-2026
- FDA event ID
- 99673
- Recalling firm
- Apotex, Weston, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Aug 2026
- FDA classified
- 27 Aug 2026
- Reported
- 2 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 13 Aug 2026 | Recall initiated by company | |
| 27 Aug 2026 | Classified by FDA | +14 days |
| 2 Sep 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Which lots are affected?
Lot # TY9494, Exp Date: 05/31/2027.
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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