Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Dextroamphetamine Saccharate Recalled by Granules Pharmaceuticals Inc. Due to Failed Impurities/Degradation Specifications:

Date: August 28, 2025
Company: Granules Pharmaceuticals Inc.
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Granules Pharmaceuticals Inc. directly.

Affected Products

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01

Quantity: 11,895 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications:

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Granules Pharmaceuticals Inc.

Granules Pharmaceuticals Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report