Quick Facts at a Glance
- Recall Date
- August 28, 2025
- Hazard Level
- HIGH
- Brand
- Granules Pharmaceuticals
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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 Capsule
- Model numbers
- GPC250158A
- UPC codes
- 70010-029, 70010-030, 70010-031, 70010-032, 70010-033, 70010-034, 70010-029-01, 70010-030-01 +4 more
- Sizes
- 100 capsules per bottle
- Sold at
- Multiple Retailers
- 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 a prescription extended-release stimulant used to treat ADHD. It is manufactured by Granules Pharmaceuticals and distributed nationwide in the USA.
Why This Is Dangerous
The product failed impurity/degradation specifications, suggesting potential undeclared impurities or degradation products.
Industry Context
This recall is not stated as part of a broader industry pattern in the notice.
Real-World Impact
Consumers may stop using the product promptly upon recall. The recall requires guidance from the manufacturer or a healthcare professional.
Practical Guidance
How to identify if yours is affected
- Check NDC 70010-029-01 on the bottle label
- Check Lot number GPC250158A
- Check Expiration date 06-22-2027
- Confirm bottle contains 100 capsules
Where to find product info
NDC appears on the Rx label; Lot and Exp appear on the bottle packaging
What timeline to expect
Not specified in the recall notice
If the manufacturer is unresponsive
- Contact your healthcare provider for guidance
- File a report with FDA MedWatch if you suspect adverse effects
- Continue to monitor FDA recall updates
How to prevent similar issues
- Ensure purchase from licensed pharmacies
- Always verify NDC before dispensing medications
- Keep batch information for future recalls
Documentation advice
Keep recall notification, batch numbers, and any correspondence with the manufacturer
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Product Details
NDC: 70010-029-01; Brand: Granules Pharmaceuticals Inc.; Product: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules; Strength: 5 mg; Form: Extended-Release Capsule; Quantity per bottle: 100 capsules; Lot: GPC250158A; Expiration: 06-22-2027; Bottles recalled: 3,384; Sold nationwide in the USA; Remedy: Stop use and contact manufacturer or healthcare provider.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot GPC250158A
- 100 capsules per bottle
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Safety Guide
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