The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0671-2025·Announced 2025-10-01

Amphetamine extended-release capsules 15 mg recalled after impurity testing failure

Mixed amphetamine salts extended-release capsules, 15 mg, lot GPC250178A, are recalled nationwide after failing impurities and degradation specifications. 9,917 bottles are affected.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: The rubric puts FDA Class III actions at 1 or 2, and this is a specification failure with no health hazard described in the notice.

Plain-English summary

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 15 mg, in 100-capsule bottles and available on prescription only, are being recalled. The affected product is lot GPC250178A with an expiry of 06-22-2027, and the recall covers 9,917 bottles distributed nationwide.

The recall was issued because the product failed impurities and degradation specifications. The FDA classified the action as Class III.

Patients should check the lot number on their bottle against the recall and should not stop taking a prescribed medicine without speaking to their pharmacist or prescriber about a replacement 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 — Central Nervous System
Hazard
Affected units
9,917

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#: GPC250178A
  • 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.

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Same hazard · failed specification

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