HIGH

Granules Pharmaceuticals Dextroamphetamine Mixed Salts ER Capsules Recall 11,909 Bottles (2025)

Granules Pharmaceuticals recalled 11,909 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules sold nationwide to pharmacies and health care providers. The recall stems from a failure to meet impurities and degradation specifications. Patients taking this prescription should stop using the product and

Quick Facts at a Glance

Recall Date
August 28, 2025
Hazard Level
HIGH
Brands
Granules Pharmaceuticals, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Failed Impurities/Degradation Specifications:

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for guidance. Notification method: E-Mail

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About This Product

This is a prescription stimulant medication used to treat ADHD and narcolepsy. It is distributed in 20 mg extended-release capsules.

Why This Is Dangerous

A failure to meet impurities/degradation specifications could introduce untested impurities, posing potential health risks.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Patients taking the affected product may need to switch therapies under professional guidance. No injuries reported yet; potential health risk requires immediate response.

Practical Guidance

How to identify if yours is affected

  1. Locate NDC 70010-032-01 on the bottle label
  2. Check Lot number GPC250179A
  3. Note expiration date 2027-06-22
  4. Verify bottle contains 20 mg strength and 100 capsules

Where to find product info

Official recall notices and FDA enforcement page for D-0672-2025

What timeline to expect

Recall processing timelines vary; not specified by the notice

If the manufacturer is unresponsive

  • Escalate to FDA recall contact channels
  • File a report with the FDA if you believe you were affected and the company is unresponsive

How to prevent similar issues

  • Verify NDC and lot numbers before dispensing or using any prescription stimulant
  • Stay informed about FDA recall notices for ADHD medications
  • Consult a healthcare provider before changing therapies

Documentation advice

Keep the recall notice, take photos of the bottle and label, document lot numbers, and maintain records of communications with the manufacturer and pharmacist

Product Details

Model numbers: NDC 70010-032-01; Lot: GPC250179A; Expiration: 2027-06-22; Quantity: 11,909 bottles; Sold nationwide to pharmacies and health care providers; Form: 20 mg, 100 capsules; Route: Rx only; Manufacturer: Granules Pharmaceuticals Inc., Chantilly, VA 20151; Price: Not disclosed; Distribution: Nationwide.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 11,909 bottles recalled
  • NDC 70010-032-01
  • Lot GPC250179A
  • Exp 06-22-2027
  • Distributed nationwide to pharmacies and healthcare providers
  • Rx only
View Original Recall on FDA - Drug Safety

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
POISONINGOTHER

Product Classification

Product TypePrescription stimulant extended-release capsules
Sold At
Multiple Retailers

Product Details

Model Numbers
GPC250179A
70010-032-01
UPC Codes
70010-029
70010-030
70010-031
+9 more
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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