Skip to content
Drug recall · FDA · Published March 31, 2021

Apotex Corp. recalls Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario

Apotex recalls 2mg Guanfacine Extended-Release Tablets due to trace quetiapine fumarate contamination. Affected lots expire Nov 2022. No action needed per official notice.

🇺🇸 FDA recall #D-0324-2021DrugApotex ›
Take action

Contact the company & request your remedy

Recalling firmApotex Corp.2400 N Commerce Pkwy Ste 400, N/A · Weston, FL 33326-3253
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Apotex is recalling 2mg Guanfacine Extended-Release Tablets that may contain trace amounts of quetiapine fumarate. This cross-contamination could pose a risk to people taking these medications. The recall does not require immediate action as the official notice states no action is needed. Read more at govinfonow.com/recall/36227-apotex-guanfacine-2mg-tablets-recall-cross-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36227-apotex-guanfacine-2mg-tablets-recall-cross-contamination-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0324-2021

Cite this page

“Apotex Guanfacine 2mg Tablets Recall: Cross Contamination Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36227-apotex-guanfacine-2mg-tablets-recall-cross-contamination-risk. Based on FDA recall #D-0324-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0324-2021%22&limit=1).

Why it’s dangerous

Trace amounts of quetiapine fumarate could be present in the product. Quetiapine is a different medication that may cause unintended side effects or interactions with the prescribed Guanfacine.

Who’s affected

People prescribed Guanfacine Extended-Release Tablets 2mg by a doctor are likely affected. Those with specific medical conditions requiring precise medication dosing may be at higher risk.

How to tell if you have this one

Check for Apotex brand Guanfacine Extended-Release Tablets 2mg, 100-count bottles with lot numbers RX1662, RX1663, or RX1664 expiring November 2022.

  • Brand
    Apotex
  • Product
    Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot numbers RX1662, RX1663, or RX1664 on the bottle label.

✎ GovInfoNow

Questions people ask

Do I need to stop using these tablets?

No action is needed per the official recall notice.

What is the risk of cross-contamination?

The product may contain trace amounts of quetiapine fumarate, which could cause unintended side effects.

How can I tell if I have the recalled product?

Check for Apotex Guanfacine Extended-Release Tablets 2mg, 100-count bottles with lot numbers RX1662, RX1663, or RX1664 expiring November 2022.

Take action

Contact Apotex

We’ve drafted a message you can send Apotex to request your refund or repair — edit it as you like.

Subject: Recall D-0324-2021 — Apotex Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex

Hello,

I own a Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario that is covered by recall D-0324-2021 from Apotex.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

Keep exploring

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

Comments are reviewed before they appear. No links, ads, or personal attacks — those get removed.

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-0324-2021 (March 31, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0324-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on October 4, 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