The Recall Desk
ModerateFDA (Drugs)·D-0673-2025·Announced 2025-10-01

Amphetamine capsules recalled for failed impurity and degradation specifications

Granules Pharmaceuticals Inc. is recalling dextroamphetamine mixed salts extended-release 30 mg capsules nationwide due to failed impurity and degradation specifications. Consumers should contact their pharmacist or doctor for guidance.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall with no reported illnesses, injuries, or deaths. Per the rubric, Class III recalls are typically scored 1 or 2, and since no illnesses are reported and the hazard is theoretical rather than confirmed, a Moderate (2) score applies.

Plain-English summary

Granules Pharmaceuticals Inc. is recalling dextroamphetamine mixed salts extended-release 30 mg capsules. The affected product lot is GPC250181A with expiration date 06-19-2027, distributed in 100-capsule bottles. Approximately 11,928 bottles were distributed nationwide in the United States.

The recall was initiated because the product failed to meet specifications for impurities and degradation. The FDA has classified this as a Class III recall.

Consumers who are currently taking this medication should contact their pharmacist or healthcare provider. They can provide their lot number or other identifying information to verify whether their specific medication is affected.

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
Hazard
  • degradation
  • contamination

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#: GPC250181A
  • Exp Date: 06-19-2027

UPCs (6)

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

Distribution

Distributed nationwide across the United States.

Related recalls

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

Same category