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Lower risk Drug recall · FDA · Published December 19, 2016

Apotex Aripiprazole Tablets 2mg Recall: Drug May Not Meet Specifications

Apotex recalls 2mg Aripiprazole tablets due to potential failure to meet specifications. This prescription drug may not be safe throughout its shelf life. Consumers should check their product details and contact Apotex for guidance.

🇺🇸 FDA recall #D-0471-2017DrugApotex ›
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Recalling firmApotex Inc.150 Signet Drive · Toronto, Canada
✎ GovInfoNow plain-language explainer

What happened, in plain English

Apotex is recalling 2mg Aripiprazole tablets because they may not meet safety specifications over time. This means the medication could be less effective or unsafe as it ages, especially for people taking it regularly. Read more at govinfonow.com/recall/42119-apotex-aripiprazole-tablets-2mg-recall-drug-may-not-meet-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/42119-apotex-aripiprazole-tablets-2mg-recall-drug-may-not-meet-specifications · Updated October 8, 2026 · FDA enforcement record: FDA #D-0471-2017

Cite this page

“Apotex Aripiprazole Tablets 2mg Recall: Drug May Not Meet Specifications.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42119-apotex-aripiprazole-tablets-2mg-recall-drug-may-not-meet-specifications. Based on FDA recall #D-0471-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0471-2017%22&limit=1).

Why it’s dangerous

The tablets may not meet the required specifications for potency or safety as they age. This could lead to inconsistent medication effects or potential health risks for patients relying on the drug.

Who’s affected

Prescription patients using Aripiprazole tablets from Apotex. Those with specific medical conditions requiring precise dosing are at higher risk.

How to tell if you have this one

Check for the product name 'Aripiprazole Tablets, 2 mg, 30-count bottle' with the lot number MJ7746 and expiration date 04/17. The product is manufactured by Apotex Inc. in Toronto, Canada.

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

What to do — step by step

  1. Check Product Details

    Look for the lot number MJ7746 and expiration date 04/17 on the packaging.

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: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 5.5 years after the firm started it.

1. Firm started the recall: Dec 19, 201612. FDA classified it Class III: Feb 9, 201723. Published in FDA’s Enforcement Report: Feb 15, 201734. FDA terminated the recall: Jun 15, 2022420162022
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-0471-2017 (December 19, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0471-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on October 8, 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