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Unrated Drug recall · FDA · Published August 28, 2025

Granules Pharmaceuticals recalls amphetamine capsules due to impurities

Granules Pharmaceuticals is recalling 20mg amphetamine capsules (NDC 70010-032-01) due to failed impurities and degradation specifications. This is a prescription product with a lot number of GPC250179A and expiration date 06-22-2027.

🇺🇸 FDA recall #D-0672-2025DrugGranules Pharmaceuticals ›
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Recalling firmGranules Pharmaceuticals Inc.3701 Concorde Pkwy · Chantilly, VA 20151-1126
✎ GovInfoNow plain-language explainer

What happened, in plain English

Granules Pharmaceuticals is recalling prescription amphetamine capsules (20mg, 100 capsules) because they failed impurities and degradation specifications. This means the product may contain harmful substances that could cause health risks if taken. Read more at govinfonow.com/recall/31822-granules-pharmaceuticals-recalls-amphetamine-capsules-due-to-impurities.

Source Summary by GovInfoNow · govinfonow.com/recall/31822-granules-pharmaceuticals-recalls-amphetamine-capsules-due-to-impurities · Updated August 17, 2026 · FDA enforcement record: FDA #D-0672-2025

Cite this page

“Granules Pharmaceuticals recalls amphetamine capsules due to impurities.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31822-granules-pharmaceuticals-recalls-amphetamine-capsules-due-to-impurities. Based on FDA recall #D-0672-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0672-2025%22&limit=1).

Why it’s dangerous

The capsules failed impurities and degradation specifications, meaning they may contain harmful substances that could cause health risks when taken. This is a prescription product that requires medical supervision.

Who’s affected

Prescription users of the 20mg amphetamine capsules (NDC 70010-032-01) with lot number GPC250179A are affected. People who have taken these capsules since their manufacture date are at risk.

How to tell if you have this one

Check for the product name 'Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate', 20mg, 100 capsules, NDC 70010-032-01, lot number GPC250179A, and expiration date 06-22-2027.

  • Brand
    Granules Pharmaceuticals
  • Category
    Drug
FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class III
  • Status
    Ongoing
  • Distribution
    Distributed Nationwide in the USA
  • NDC
    70010-029-01, 70010-030-01, 70010-031-01, 70010-032-01, 70010-033-01, 70010-034-01
Recall numberProduct, codes & lotsQuantity
D-0669-2025Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01; Lot#: GPC250158A, Exp Date: 06-22-20273,384 bottles
D-0670-2025Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01; lot#: GPC250159A, Exp Date: 06-22-202711,895 bottles
D-0671-2025Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01; Lot#: GPC250178A, Exp Date: 06-22-20279,917 bottles
D-0672-2025Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01; Lot#: GPC250179A, Exp Date: 06-22-202711,909 bottles
D-0673-2025Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01; Lot#: GPC250181A, Exp Date: 06-19-202711,928 bottles
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the NDC code 70010-032-01 and lot number GPC250179A on the product 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: “Distributed 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 published this recall 34 days after the firm started it.

1. Firm started the recall: Aug 28, 202512. FDA classified it Class III: Sep 24, 202523. Published in FDA’s Enforcement Report: Oct 1, 202532025
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report

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-0672-2025 (August 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0672-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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