The Recall Desk
LowFDA (Drugs)·D-0669-2025·Announced 2025-10-01

Dextroamphetamine Saccharate and Amphetamine Capsules Recalled for Failed Impurities Specifications

Granules Pharmaceuticals Inc. is recalling 3,384 bottles of mixed-salt amphetamine extended-release capsules (5 mg) distributed nationwide due to failed impurities and degradation specifications.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall, which by definition is unlikely to cause adverse health consequences. No illnesses, injuries, or deaths are reported in the source text, and the hazard is a manufacturing specification failure rather than an acute safety threat.

Plain-English summary

Granules Pharmaceuticals Inc. is recalling Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate extended-release capsules, 5 mg (100-capsule bottles, NDC 70010-029-01 and related package NDCs) due to failed impurities and degradation specifications. The affected lot is GPC250158A with an expiration date of 06-22-2027.

The recalled product was distributed nationwide in the USA. Patients taking this medication should consult their healthcare provider or pharmacist to determine whether they received affected product and for guidance on obtaining an alternative supply.

The recalled product

Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Brand
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Manufacturer
Granules Pharmaceuticals Inc.
Category
Drug — Amphetamine / Extended-Release Oral
Hazard
Affected units
3,384

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot#: GPC250158A
  • Exp Date: 06-22-2027

UPCs (6)

  • 0370010029019
  • 0370010030015
  • 0370010032019
  • 0370010034013
  • 0370010031012
  • 0370010033016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Granules Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same brand · DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE

Same manufacturer · Granules Pharmaceuticals Inc.

See all →

Same hazard · impurity degradation

See all →