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Use caution Drug recall · FDA · Published September 23, 2026

Apotex Recalls Paroxetine 37.5mg Due to Dissolution Failure

Apotex Corp. recalls specific lots of Paroxetine Extended-Release Tablets, 37.5mg, because they failed dissolution specifications.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0877-2026DrugApotex ›
✎ GovInfoNow plain-language explainer

Apotex Corp. is recalling one lot of Paroxetine Extended-Release Tablets, 37.5mg, because the product failed dissolution specifications. This means the tablets may not release the medication properly in the body. The recall affects units distributed nationwide in the United States. Read more at govinfonow.com/recall/1443822-apotex-corp-recalls-paroxetine-extended-release-tablets-37-5mg-30.

Source Summary by GovInfoNow · govinfonow.com/recall/1443822-apotex-corp-recalls-paroxetine-extended-release-tablets-37-5mg-30 · Published October 13, 2026 · Updated October 13, 2026 · FDA enforcement record: FDA #D-0877-2026

Cite this page

“Apotex Recalls Paroxetine 37.5mg Due to Dissolution Failure.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/1443822-apotex-corp-recalls-paroxetine-extended-release-tablets-37-5mg-30. Based on FDA recall #D-0877-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0877-2026%22&limit=1).

The FDA announced on Sept. 23, 2026, that Apotex Corp. is recalling Paroxetine Extended-Release Tablets due to failed dissolution specifications. Owners should contact the company for a refund.

How to tell if you have it

  • Brand: Apotex
  • Product: Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle
  • NDC: 60505-1318-3
  • Lot#: TY9495
  • Exp Date: 05/2027

The hazard

The tablets failed dissolution specifications, meaning they may not release the drug properly. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Apotex Corp. has 24 other recalls on record since 2007-06-14. Other recent recalls of similar products include Apotex Paxil CR 37.5mg Tablets Recall (2026-08-13), Apotex Desmopressin Nasal Spray Recall (2026-04-08), and Apotex Brimonidine/Timolol Eye Drops Recall (2026-03-05). Other recent recalls of similar products include Ajanta Pharma Recalls Ranolazine 1000mg Due to Dissolution Failure (2026-09-17) and Teva Metoprolol Succinate Extended-Release Tablets Recall (2026-01-29).

How to tell if you have this one

Check your bottle for the following details: Product name 'Paroxetine Extended-Release Tablets, 37.5mg', NDC 60505-1318-3, Lot# TY9495, and Expiration Date 05/2027.

  • Brand
    Apotex
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check your medication bottle

    Verify if your Paroxetine Extended-Release Tablets match the recalled NDC 60505-1318-3 and Lot# TY9495.

  2. Contact your pharmacist or doctor

    Speak with your healthcare provider about how to proceed with your treatment plan.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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 14 days after the firm started it.

1. Firm started the recall: Sep 23, 202612. FDA classified it Class II: Sep 29, 202623. Published in FDA’s Enforcement Report: Oct 7, 202634. Added to GovInfoNow: Oct 13, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

Similar recalls

Apotex Paxil CR 37.5mg Tablets Recall: Failed Stability Testing
ApotexAjanta Pharma Recalls Ranolazine 1000mg Due to Dissolution Failure
Ajanta Pharma USA IncClear Eyes Eye Drops Recall: Lack of Sterility Risk
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare companyAmneal Estradiol Gel Recall: Defective Empty or Partial Packets
Amneal Pharmaceuticals, LLCInventia Chlorthalidone Recall: Failed Dissolution Specs
Inventia Healthcare Limited

Other Apotex recalls

Apotex Corp. recalls Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario,
April 8, 2026Apotex Corp. recalls Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured
March 5, 2026Apotex Corp. recalls Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection
February 2, 2021

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Keep exploring

Where this comes from

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-0877-2026 (September 23, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0877-2026 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA