Quick Facts at a Glance
- Recall Date
- August 28, 2025
- Hazard Level
- HIGH
- Brands
- Dextroamphetamine Saccharate, Granules Pharmaceuticals Inc.
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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
- Dextroamphetamine Saccharate, Granules Pharmaceuticals Inc.
- Product type
- Extended-Release Capsules (Mixed Salts of a Single Entity Amphetamine Product)
- Model numbers
- lot#: GPC250159A, Exp Date: 06-22-2027
- UPC codes
- 70010-029, 70010-030, 70010-031, 70010-032, 70010-033, 70010-034, 70010-029-01, 70010-030-01 +4 more
- Sizes
- 10 mg, 100 capsules
- 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 is a prescription extended-release amphetamine product used for ADHD and narcolepsy in adults and certain patients. It is manufactured by a US facility.
Why This Is Dangerous
The defect relates to impurities/degradation specifications which could affect safety, but specific health effects are not detailed in the release.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
No injuries reported yet; immediate stop-use is required to prevent potential risk and ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Look for NDC 70010-030-01 on the bottle
- Check lot: GPC250159A
- Verify Exp Date: 06-22-2027
- Manufactured by Granules Pharmaceuticals Inc.
Where to find product info
FDA recall page D-0670-2025 and manufacturer communications
What timeline to expect
Remedies and refunds typically processed within several weeks to a few months depending on manufacturer policy
If the manufacturer is unresponsive
- Escalate to FDA recall contacts
- File complaint with FDA if no response from the manufacturer
- Consult healthcare provider for alternatives and referrals
How to prevent similar issues
- Verify supplier recalls before dispensing
- Track lot-level recalls in pharmacy inventory systems
- Educate patients about checking bottle labels for lot numbers in future purchases
Documentation advice
Keep recall notices, bottle labels, and communications with the manufacturer; document any adverse events.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Brand: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate. Manufacturer: Granules Pharmaceuticals Inc., Chantilly, VA 20151. NDC: 70010-030-01. Quantity: 11,895 bottles. Sold nationwide in the USA. Date codes/lot: lot#: GPC250159A. Expiration: 06-22-2027. Reminder: Rx only.
Reported Incidents
No specific injuries or adverse events are reported in the available notice.
Key Facts
- Lot#: GPC250159A
- High hazard level
- Active recall as of 2025-10-01
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
