Skip to content
Back to recalls
Drug FDA Class III Ongoing Failed specifications

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 7

Granules Pharmaceuticals Inc. Published Oct 1, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Granules Pharmaceuticals Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Impurities/Degradation Specifications:

Hazards

Failed Impurities/Degradation Specifications · primary

Affected products (1)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE · 3,384 bottles

NDC: 70010-029, 70010-030, 70010-031, 70010-032, 70010-033, 70010-034, 70010-029-01, 70010-030-01, 70010-031-01, 70010-032-01, 70010-033-01, 70010-034-01
Code info: Lot#: GPC250158A, Exp Date: 06-22-2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 28, 2025
  2. Published
    Oct 1, 2025
Recall number
D-0669-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.