Quick Facts at a Glance
- Recall Date
- August 28, 2025
- Hazard Level
- HIGH
- Brand
- Granules Pharmaceuticals
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Granules Pharmaceuticals
- Product type
- Extended-Release Amphetamine Capsule
- Model numbers
- GPC250181A
- UPC codes
- 70010-029, 70010-030, 70010-031, 70010-032, 70010-033, 70010-034, 70010-029-01, 70010-030-01 +4 more
- Sizes
- 30 mg, 100 capsules per bottle
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 28, 2025
Reported by FDA DRUG
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
This product is an extended-release amphetamine capsule formulated as a mixed salts product for ADHD. It is Rx-only and distributed nationwide in the USA.
Why This Is Dangerous
The failure to meet impurity and degradation specifications may affect safety and efficacy, potentially impacting patient treatment outcomes.
Industry Context
This recall is not shown as part of a broader industry pattern in the provided data.
Real-World Impact
Disruption to ADHD treatment; potential need for clinician adjustment and monitoring; immediate stop-use recommended.
Practical Guidance
How to identify if yours is affected
- Verify NDC 70010-034-01 on packaging
- Check for 30 mg strength and 100 capsules per bottle
- Confirm Granules Pharmaceuticals as the manufacturer
Where to find product info
FDA recall page and Granules Pharmaceuticals communications
What timeline to expect
Refund or replacement timelines not provided; consult FDA notice for updates
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer
- File a consumer complaint with the FDA if manufacturer is non-responsive
- Seek guidance from your pharmacist or clinician
How to prevent similar issues
- Verify manufacturers and NDC codes before dispensing/using medications
- Watch for FDA recall updates and batch alerts
- Consult prescribing clinician before stopping or changing medications
Documentation advice
Keep product packaging, recall notice, and all communications with the manufacturer; log lot numbers and dates of purchase
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Product Details
Product: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, 30 mg, 100 capsules per bottle. Manufacturer: Granules Pharmaceuticals Inc., Chantilly, VA 20151. NDC: 70010-034-01. Classification: Class III. Distributed nationwide in the USA.
Reported Incidents
No specific injuries or incidents are reported in the recall notice. The FDA enforcement report lists the issue but does not detail injuries.
Key Facts
- Class III recall
- Nationwide distribution in the USA
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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