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
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
- Prescription analgesic/psychotropic capsule
- Model numbers
- GPC250178A
- UPC codes
- 70010-029, 70010-030, 70010-031, 70010-032, 70010-033, 70010-034, 70010-029-01, 70010-030-01 +4 more
- Sizes
- 15 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
Amphetamine formulations are prescription stimulants used to treat ADHD and narcolepsy. This recall involves extended-release capsules containing mixed salts of amphetamine.
Why This Is Dangerous
The failure relates to impurities or degradation products in the capsule formulation which could affect safety and efficacy.
Industry Context
This recall is not identified as part of a broader industry pattern in the provided data.
Real-World Impact
No injuries reported yet; immediate discontinuation is advised to mitigate any potential risk to patients and preserve treatment integrity.
Practical Guidance
How to identify if yours is affected
- Inspect Lot GPC250178A
- Confirm packaging shows Granules Pharmaceuticals, Chantilly VA
Where to find product info
FDA recall page and manufacturer notification by email
What timeline to expect
Refunds/replacements timelines vary; expect updates within weeks
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer
- File report with FDA if nonresponsive
- Seek alternative prescriptions via your healthcare provider
How to prevent similar issues
- Verify NDC and lot before dispensing
- Prefer suppliers with transparent impurity testing results
- Review stability data for similar amphetamine products
Documentation advice
Keep product packaging, photos of lot/expiration, and all correspondence
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Product Details
Brand: Granules Pharmaceuticals. Product: Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate; Extended-Release Capsules, 15 mg, 100 capsules. NDC: 70010-031-01. Lot: GPC250178A. Expiration: 06-22-2027. Distributed nationwide in the USA. Quantity recalled: 9,917 bottles.
Reported Incidents
No specific injuries or adverse events are reported in the provided notice.
Key Facts
- Lot GPC250178A
- FDA recall number D-0671-2025
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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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