HIGH

Granules Pharmaceuticals Recalls 3,384 Bottles of Dextroamphetamine ER Capsules for Impurity Issues

Granules Pharmaceuticals Inc. recalls 3,384 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, 100 capsules per bottle, NDC 70010-029-01, Lot GPC250158A, Exp 06-22-2027. The recall concerns failed impurities/degradation specifications. Healthcare providers and consumers should stop using the

Quick Facts at a Glance

Recall Date
August 28, 2025
Hazard Level
HIGH
Brand
Granules Pharmaceuticals
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Failed Impurities/Degradation Specifications:

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for guidance. Notification method: E-Mail

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About This Product

This product is a prescription extended-release stimulant used to treat ADHD. It is manufactured by Granules Pharmaceuticals and distributed nationwide in the USA.

Why This Is Dangerous

The product failed impurity/degradation specifications, suggesting potential undeclared impurities or degradation products.

Industry Context

This recall is not stated as part of a broader industry pattern in the notice.

Real-World Impact

Consumers may stop using the product promptly upon recall. The recall requires guidance from the manufacturer or a healthcare professional.

Practical Guidance

How to identify if yours is affected

  1. Check NDC 70010-029-01 on the bottle label
  2. Check Lot number GPC250158A
  3. Check Expiration date 06-22-2027
  4. Confirm bottle contains 100 capsules

Where to find product info

NDC appears on the Rx label; Lot and Exp appear on the bottle packaging

What timeline to expect

Not specified in the recall notice

If the manufacturer is unresponsive

  • Contact your healthcare provider for guidance
  • File a report with FDA MedWatch if you suspect adverse effects
  • Continue to monitor FDA recall updates

How to prevent similar issues

  • Ensure purchase from licensed pharmacies
  • Always verify NDC before dispensing medications
  • Keep batch information for future recalls

Documentation advice

Keep recall notification, batch numbers, and any correspondence with the manufacturer

Product Details

NDC: 70010-029-01; Brand: Granules Pharmaceuticals Inc.; Product: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules; Strength: 5 mg; Form: Extended-Release Capsule; Quantity per bottle: 100 capsules; Lot: GPC250158A; Expiration: 06-22-2027; Bottles recalled: 3,384; Sold nationwide in the USA; Remedy: Stop use and contact manufacturer or healthcare provider.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 3,384 bottles recalled
  • NDC 70010-029-01
  • Lot GPC250158A
  • Exp 06-22-2027
  • 100 capsules per bottle
  • Rx only
View Original Recall on FDA - Drug Safety

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
POISONINGOTHER

Product Classification

Product TypeExtended-Release Capsule
Sold At
Multiple Retailers

Product Details

Model Numbers
GPC250158A
UPC Codes
70010-029
70010-030
70010-031
+9 more
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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