Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only… recall
FDA recall D-0804-2026 · initiated Aug 13, 2026
Apotex Corp. recalled Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx… in Aug 2026 — an FDA Class II recall (D-0804-2026) because Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6,972 bottles
Details
- Product
- 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
- Recalling company
- Apotex
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Aug 13, 2026
- FDA report date
- Sep 2, 2026
Frequently asked
- Was Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx… recalled?
- Apotex Corp. recalled Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx… in Aug 2026 — an FDA Class II recall (D-0804-2026) because Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx… recalled?
- Per the FDA enforcement record, the reason for recall D-0804-2026 was: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
- Is a recalled Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx… are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # TY9494, Exp Date: 05/31/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0804-2026.