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Lower risk Drug recall · FDA · Published April 17, 2018

Rhodes Aptensio XR 15mg Capsules: Failed Dissolution Risk

Rhodes Pharmaceuticals recalls 15mg Aptensio XR capsules due to potential low dissolution outside specifications. This may affect medication effectiveness. Check NDC 42858-402-45 and lot number AG8679B.

🇺🇸 FDA recall #D-0710-2018DrugRhodes Pharmaceuticals ›
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Contact the company

Recalling firmRhodes Pharmaceuticals, L.P.498 Washington St · Coventry, RI 02816-5467
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What happened, in plain English

Rhodes Pharmaceuticals is recalling 15mg Aptensio XR capsules because they may not dissolve properly as intended. This could lead to inconsistent medication levels, which might affect treatment effectiveness. Read more at govinfonow.com/recall/40610-rhodes-aptensio-xr-15mg-capsules-failed-dissolution-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/40610-rhodes-aptensio-xr-15mg-capsules-failed-dissolution-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0710-2018

Cite this page

“Rhodes Aptensio XR 15mg Capsules: Failed Dissolution Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40610-rhodes-aptensio-xr-15mg-capsules-failed-dissolution-risk. Based on FDA recall #D-0710-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0710-2018%22&limit=1).

Why it’s dangerous

The capsules may not dissolve properly as intended, which could lead to inconsistent medication levels. This might affect how well the medication works for treating conditions like ADHD.

Who’s affected

People prescribed 15mg Aptensio XR capsules by a doctor. Those using the product without a prescription are not affected since it's Rx only.

How to tell if you have this one

Check for the NDC code 42858-402-45 and lot number AG8679B on the bottle. The product is a 90-count bottle of 15mg capsules sold by Rhodes Pharmaceuticals.

  • Brand
    Rhodes Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the NDC code 42858-402-45 and lot number AG8679B on the bottle.

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 within 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 2.1 years after the firm started it.

1. Firm started the recall: Apr 17, 201812. FDA classified it Class III: May 3, 201823. Published in FDA’s Enforcement Report: May 9, 201834. FDA terminated the recall: May 19, 2020420182020
  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.

✎ GovInfoNow

Questions people ask

Is this product available over the counter?

No, this product is prescription-only (Rx only) and requires a doctor's prescription.

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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-0710-2018 (April 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0710-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on October 7, 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