CLASS II ONGOING Drug recall · Reported 7 Oct 2026 · FDA Enforcement Report
Paroxetine Extended-Release Tablets, 37.5mg recalled by Apotex
Apotex is recalling Paroxetine Extended-Release Tablets, 37.5mg, distributed nationwide in the US. The recall was initiated on 23 Sep 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-0877-2026
- FDA event ID
- 99978
- Recalling firm
- Apotex, Weston, FL
- Manufacturer
- Apotex Corp
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Sep 2026
- FDA classified
- 29 Sep 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 23 Sep 2026 | Recall initiated by company | |
| 29 Sep 2026 | Classified by FDA | +6 days |
| 7 Oct 2026 | Published in enforcement report | +8 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.
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
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 60505-1318-3
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Failed dissolution specifications.
Which lots are affected?
Lot# TY9495, Exp Date: 05/2027.
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 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Apotex
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled | Apotex | Other | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
Other Paroxetine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by Apotex | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine tablets, USP, 20 mg, Packaged as a) recalled | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by Apotex | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine tablets, USP, 40 mg, Packaged as a) recalled | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by Apotex | Apotex | Potency & Assay | Nationwide |