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Drug recall · FDA · Published November 11, 2020

Apotex Corp. recalls Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC

Apotex recalls 15mg Aripiprazole tablets that failed dissolution tests. These prescription-only pills may not release medication properly. Consumers should contact Apotex for details.

🇺🇸 FDA recall #D-0106-2021DrugApotex ›
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 15mg Aripiprazole tablets that failed dissolution tests. This means the medication might not release properly in the body, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/36684-apotex-aripiprazole-15mg-tablets-failed-dissolution-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/36684-apotex-aripiprazole-15mg-tablets-failed-dissolution-specifications · Updated October 4, 2026 · FDA enforcement record: FDA #D-0106-2021

Cite this page

“Apotex Aripiprazole 15mg Tablets: Failed Dissolution Specifications.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36684-apotex-aripiprazole-15mg-tablets-failed-dissolution-specifications. Based on FDA recall #D-0106-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0106-2021%22&limit=1).

Why it’s dangerous

The tablets failed dissolution tests, meaning they may not release medication properly in the body. This could lead to inconsistent dosing and treatment effectiveness. However, the recall does not indicate immediate safety risks like injury or death.

Who’s affected

Prescription patients who have the 1000-count or 30-count bottles of Aripiprazole 15mg tablets with the specified NDC numbers. People taking this medication for mental health conditions are most at risk.

How to tell if you have this one

Check for 15mg Aripiprazole tablets in 1000-count bottles (NDC 60505-2675-8) or 30-count bottles (NDC 60505-2675-3). These are prescription-only medications sold with specific expiration dates.

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

What to do — step by step

  1. Check Product Details

    Identify the NDC numbers and expiration dates on the packaging to confirm if your tablets are affected.

✎ GovInfoNow

Questions people ask

Why is this medication being recalled?

The tablets failed dissolution specifications, meaning they may not release medication properly in the body.

What should I do if I have the recalled tablets?

Contact Apotex directly for instructions on what to do with the recalled tablets.

Are there any safety risks from using these tablets?

The recall indicates potential treatment effectiveness issues, but no immediate safety risks like injury or death.

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-0106-2021 — Apotex Apotex

Hello,

I own a Apotex that is covered by recall D-0106-2021 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.

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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-0106-2021 (November 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0106-2021 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