Apotex recalls 37.5mg Paxil CR tablets due to failing 24-month stability tests. This may affect medication safety. Check your prescription bottle for NDC 60505-4379-3.
“Apotex Paxil CR 37.5mg Tablets Recall: Failed Stability Testing.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/692847-apotex-paxil-cr-37-5mg-tablets-recall-failed-stability-testing. Based on FDA recall #D-0804-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0804-2026%22&limit=1).
Apotex Corp. voluntarily recalled Paxil CR and Paroxetine Extended-Release Tablets due to failed dissolution specifications, the Food and Drug Administration said on Aug. 13, 2026. The Class II recall affects 6,972 bottles distributed nationwide.
The product failed to meet 24-month stability testing acceptance criteria, according to the FDA. The recall is classified as Class II.
Context
GovInfoNow's records show Apotex Corp. has 23 other recalls on record since June 14, 2007. Other recent recalls of similar products include Apotex Desmopressin Nasal Spray Recall (April 8, 2026), Apotex Brimonidine/Timolol Eye Drops Recall (March 5, 2026), and Apotex Brimonidine/Timolol Eye Drops Recall (Sept. 5, 2025). Other recent recalls of similar products include Safecor Health Fluphenazine Elixir Recall (Aug. 13, 2026), Mylan Prasugrel Tablets Recall (Aug. 17, 2026), and Cipla Phytonadione Injectable Emulsion Recall (Oct. 31, 2025).
How to tell if you have this one
Check for the NDC code 60505-4379-3 on the bottle. Look for the lot number TY9494 and expiration date 05/31/2027.
Brand
Apotex
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Medication
Look for the NDC code 60505-4379-3 on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 20 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0804-2026 (August 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0804-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.