HIGH

Granules Pharmaceuticals Amphetamine Capsules Recalled for Impurities Degradation Standards (2025)

Granules Pharmaceuticals recalled 9,917 bottles of mixed-salts amphetamine extended-release capsules nationwide. The recall was issued August 28, 2025 and remains active. The FDA cited failed impurities/degradation specifications as the reason. Healthcare providers and consumers should stop using the product immediately and contact Granules Pharmaceuticals for guidance.

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

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

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

  1. Check NDC 70010-031-01
  2. Inspect Lot GPC250178A
  3. Verify expiration 06-22-2027
  4. 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

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

  • 9,917 bottles recalled
  • NDC 70010-031-01
  • Lot GPC250178A
  • Expiration 06-22-2027
  • FDA recall number D-0671-2025
  • Recall date 2025-08-28
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
GENERALPREGNANT
Injury Types
POISONINGELECTRICAL

Product Classification

Product TypePrescription analgesic/psychotropic capsule
Sold At
Unknown

Product Details

Model Numbers
GPC250178A
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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