What specific lot or batch is affected?

The recall specifies 11,928 bottles with NDC 70010-034-01 but does not list batch/lot numbers in the provided data. Check FDA recall notice for lot details.

Is there a replacement or refund offered?

The notice instructs stopping use and contacting Granules for guidance. Details on refunds or replacements are not provided in the provided text; refer to FDA notice.

What should I do if I already used some of this medication?

Consult your healthcare provider. Do not discontinue or adjust treatment without professional guidance unless directed by your clinician.

How can I verify my product is affected?

Check the NDC 70010-034-01 on the product packaging and compare with FDA recall notice.

Where can I get more information?

Visit the FDA enforcement report linked in the recall (D-0673-2025) and the Granules Pharmaceuticals communications.

What are the safety risks of using an affected product?

The recall cites failed impurities/degradation specifications which could impact safety and efficacy; consult a clinician for guidance.

Can the product still be used if I suspect a defect?

No. The recall advises stopping use immediately and seeking guidance from a healthcare provider.

Will the product be replaced at no cost?

Replacement or refund details are not specified in the provided material; users should contact Granules for instructions.

Is this recall part of a larger pattern of amphetamine recalls?

The provided data does not indicate a broader pattern; it is a Class III recall for this specific product.

What is the status of the recall?

The recall status is ACTIVE as of the report date.

HIGHAugust 28, 2025

Granules Pharmaceuticals Recall: 11,928 Bottles of Dextroamphetamine Mixed Salts Suspended for Impur

Granules Pharmaceuticals recalled 11,928 bottles of an extended-release amphetamine product. The recall date is 2025-08-28 for Dextroamphetamine saccharate and related salts. The FDA lists the reason as failed impurities and degradation specifications. The recall remains active as of 2025-10-01. Health care providers and patients should stop use and contact the manufacturer 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, PETS

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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

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

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

11,928 bottles recalled
30 mg strength
NDC 70010-034-01
Class III recall
Nationwide distribution in the USA

View Original Recall on FDA - Drug Safety

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 Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERALPREGNANTPETS

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Drugs & Medications

Product TypeExtended-Release Amphetamine Capsule

Product Details

Brand

Granules Pharmaceuticals

Related Recalls

Health & Personal Care

HIGH

Granules Pharmaceuticals Recalls 3,384 Bottles of Dextroamphetamine ER Capsules for Impurity Issues

Granules Pharmaceuticals Inc. recalls 3,384 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, 100 capsules per bottle, NDC 70010-029-01, Lot GPC250158A, Exp 06-22-2027. The recall concerns failed impurities/degradation specifications. Healthcare providers and consumers should stop using the

Aug 28, 2025

Granules Pharmaceuticals

Failed Impurities/Degradation

Health & Personal Care

HIGH

Granules Pharmaceuticals Dextroamphetamine Mixed Salts ER Capsules Recall 11,909 Bottles (2025)

Granules Pharmaceuticals recalled 11,909 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules sold nationwide to pharmacies and health care providers. The recall stems from a failure to meet impurities and degradation specifications. Patients taking this prescription should stop using the product and

Aug 28, 2025

Granules Pharmaceuticals

Failed Impurities/Degradation

Health & Personal Care

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.

Aug 28, 2025

Granules Pharmaceuticals

Failed Impurities/Degradation